J Gastrointest Canc (2014) 45:181–189 DOI 10.1007/s12029-014-9605-z
ORIGINAL RESEARCH
A Systematic Review of Randomized Controlled Trials Testing the Efficacy of Psychosocial Interventions for Gastrointestinal Cancers Jennifer L. Steel & Kathryn Bress & Lydia Popichak & Jonathan S. Evans & Alexandra Savkova & Michelle Biala & Josh Ordos & Brian I. Carr
Published online: 15 April 2014 # Springer Science+Business Media New York 2014
Abstract Introduction Psychological morbidity in those diagnosed with cancer has been shown to result in poorer quality of life and increase the risk of mortality. As a result, researchers have designed and tested psychosocial interventions to improve quality of life and survival of patients diagnosed with cancer. Methods A systematic review of the literature was performed to describe the psychosocial interventions that have been tested in patients with gastrointestinal cancers. Databases such as MEDLINE, PsychINFO, PubMed, MedLine, and Cochrane Reviews were searched. The searches were inclusive of studies published in English between 1966 and October 2013. Raters conducted full-text review of the resulting articles for the following eligibility criteria: (1) participants were 18 years or older, (2) the majority of patients in the sample were diagnosed with a gastrointestinal cancer, (3) the trial was testing a psychosocial intervention, and (4) random assignment to one or more interventions versus a usual care, placebo, attention control, or waiting-list control condition. Results The interventions that were eligible for this review included psychosocial or behavioral intervention (e.g., cognitive behavioral therapy, problem solving, educational, and collaborative care), physical activity, and/or psychopharmacologic treatment (e.g., selective serotonin reuptake inhibitor). Interventions that included dietary changes were not included in the present review. Study quality was also assessed using the Physiotherapy Evidence Database (PEDro) system. The results of the review resulted in a finding of eight studies to J. L. Steel (*) : K. Bress : L. Popichak : J. S. Evans : A. Savkova : M. Biala : J. Ordos Department of Surgery, University of Pittsburgh School of Medicine, 3459 Fifth Avenue; Montefiore 7S, Pittsburgh, PA 15213, USA e-mail: [email protected] B. I. Carr Liver Cancer Program, IRCCS de Bellis, Bari, Italy
have been conducted, testing psychosocial interventions, in patients with gastrointestinal cancers. Findings of these studies suggested that the interventions were effective in reducing psychological and physical symptoms associated with the cancer, improved quality of life, and reduced immune system dysregulation, and one study demonstrated an improvement in survival. Two studies reported no benefit from psychosocial intervention when compared with a control group. The quality of the studies varied greatly, but reporting of the details of the trials, and the methodological rigor, improved over time. Conclusion Further research is warranted to design and test interventions that may be effective in patients diagnosed with gastrointestinal cancers. Keywords Systematic review . Gastrointestinal cancers . Intervention . Psychosocial
Introduction Psychological morbidity has been shown to significantly reduce quality of life and even increase the risk of mortality in people diagnosed with cancer [1–3]. As a result, decades of research testing the effectiveness of psychosocial interventions to reduce psychological morbidity such as anxiety and depression, improve health behaviors, and overall quality of life have been conducted. Such a large body of research exists, in which several systematic reviews and meta-analyses have been performed to describe the overall findings of these studies [4, 5]. Overall, these interventions have been shown to reduce depression and anxiety and improve quality of life and immune system functioning [4, 6–9]. Interventions that were delivered individually and were longer in duration (>12 weeks) were found to be most effective [7].
182
One of the most controversial areas that continues to be debated is whether psychosocial interventions improve survival. Smedslund and Ringdal found mixed results with regard to the role of psychosocial interventions on survival [4]. Psychosocial interventions delivered to the individual, rather than in a group, were found to have significant improvements in survival [4]. Chow and colleagues [5] analyzed eight trials that assessed the efficacy of psychosocial interventions in improving survival. These researchers also found that the patients in the intervention arms of the studies had an improvement in survival when compared with those in the usual care arm [5]. Although these meta-analytic studies demonstrated that the psychosocial interventions were effective, the size of the effect was often small [4, 5]. Furthermore, research conducted examining the effectiveness of psychosocial interaction was unexclusive because the investigators included patients who did not have clinically significant symptoms [4, 5]. Hart and colleagues [10] demonstrated that studies testing the efficacy of psychosocial intervention, which screened for patients with clinical levels of depressive symptoms, had larger effect sizes. Despite the decades of research in testing psychosocial interventions to reduce psychological symptoms and improve quality of life and survival, few studies have been published that have tested the effectiveness of psychosocial interventions in patients diagnosed with gastrointestinal cancers. The aims of this systematic review were to provide a summary of the findings from studies that have targeted patients diagnosed with gastrointestinal cancers. Given the advanced stage in which many gastrointestinal cancers present and the importance of maintaining quality of life, the benefit of psychosocial interventions may be great for this patient population.
Methods Database Search For the purposes of this paper, gastrointestinal cancer included neoplasms of the stomach, colon, esophagus, liver, gallbladder, and bile ducts. We did not include mixed heterogeneous samples of cancer patients in this review unless the majority of the sample included gastrointestinal cancer patients. Databases were searched, including MEDLINE, PsycINFO, PubMed, MedLine, and Cochrane. The keyword searches used were: “psychosocial intervention,” “intervention,”,“psychological treatment,” and “cancer or neoplasm.” The search of studies was performed using a Boolean operator, “and” and “or”, limiting the search to randomized controlled studies. The searches were inclusive of studies published in English between 1966 and October 2013. We also examined the references of the articles identified through the searches, relevant reviews and meta-analyses.
J Gastrointest Canc (2014) 45:181–189
Inclusion Criteria Retrieved studies were independently assessed for relevance by two reviewers (SA and JS) and included if all of the inclusion criteria were met. Raters (SA and LP) conducted full-text review of the resulting articles for the following eligibility criteria: (1) adult participants (18 years or older) with a cancer diagnosis at the time of study entry; (2) inclusion criterion that included a trial testing a psychosocial intervention in a sample of gastrointestinal cancer patients; and (3) random assignment to one or more interventions versus a usual care, placebo, attention control, or waiting-list control condition. Interventions that were included in this review included psychosocial or behavioral intervention including psychotherapy (e.g., cognitive behavioral therapy, problem solving, educational, and collaborative care), physical activity, and/or psychopharmacologic treatment (e.g., selective serotonin reuptake inhibitor) and supportive care. Interventions that included dietary changes were not included in the present review. Data Extraction Predesigned tables were used to ensure that data extraction was standardized. Extracted information included: the number of individuals invited to participate, number of participants randomly assigned, demographic characteristics, cancer type, stage, setting, point in medical treatment, funding source, time since diagnosis, recruitment method, intervention type, delivery, duration, total dose of intervention, control arm, screening criterion, timing of assessment, and outcome type. Study Quality Studies were assessed for quality using the Physiotherapy Evidence Database (PEDro) scale which was designed to identify studies that are generalizable, internally valid, and Interpretable [11].
Results Gastrointestinal cancers are the subject of proportionally few cancer-related studies. A total of eight studies have been conducted with this patient population [12–19]. The intervention types include physical activity (n=2), psychosocial (n= 4), and supportive or palliative care (n=2). See Table 1 for details of the studies. The summary of the studies can be found below. Physical Activity Na and colleagues [12] examined the effect of an exercise intervention on natural killer cell cytotoxic activity (NKCA)
249 61
279
592 Not reported
Not reported
Inpatient
All stages UICC II or III
Heterogenous, majority of patients with GI cancer Colorectal
Steel, Kim, Geller, Marsh, Antoni, Dew, Schulz, and Tsung [17] Allgayer, Nicolaus, and Schreiber, 2004 [13] Steel, Nadeau, Olek, and Carr, 2007 [16] HCC, gallbladder, or cholangio
Outpatient
Not reported
Colorectal
Advanced cancer
Not reported
Outpatient
Outpatient
Outpatient
Outpatient
Inpatient Inpatient (95 %)
Not reported
Ross, Thomsen, Karlsen, Boesen, and Johansen, 2005 [14]
Not reported Not reported
Gastric adenocarcinoma
Inpatient or outpatient
Glimelius, Ekstrom, Hoffman, Graf, Sjoden, Haglund, Svensson, Enander, Linne, Sellstrom, and Heuman [18] Cunningham, Pyhornen, James, Punt, Hickish, and Heikkila [19]
Stage
14
Stomach Esophageal, stomach, liver/gallbladder, pancreas, colon, or rectal Colon
28
30
Not reported
Na, Kim, Kim, Ha, and Yoon, 2000 [12] Kuchler, Bestmann, Rappat, Henne-Bruns, and Wood-Dauphinee, 2007 [15]
23
Not reported
178
Cancer type
261
340
Not reported
Not reported
171
42
35
No. of participants postintervention
Author, publication date, (reference)
Steel, Kim, Geller, Marsh, Antoni, Dew, Schulz, and Tsung [17] Allgayer, Nicolaus, and Schreiber, 2004 [13] Steel, Nadeau, Olek, and Carr, 2007 [16]
272
705
Kuchler, Bestmann, Rappat, Henne-Bruns, and Wood-Dauphinee, 2007 [15] Ross, Thomsen, Karlsen, Boesen, and Johansen, 2005 [14] Glimelius, Ekstrom, Hoffman, Graf, Sjoden, Haglund, Svensson, Enander, Linne, Sellstrom, and Heuman [18] Cunningham, Pyhornen, James, Punt, Hickish, and Heikkila [19]
35
Not reported
Na, Kim, Kim, Ha, and Yoon, 2000 [12]
No. of patients randomly assigned
No. of individuals invited to participate
Author, publication date, (reference)
Table 1 Characteristics of studies
Newly diagnosed
Postprimary treatment
Postdiagnoses of metastatic colorectal cancer Newly diagnosed
Postdiagnosis of noncurable gastric adenocarcinoma
Postoperation
Postopeartive day 2 Pre- and postoperation
Point in medical treatment
67
ME group, 49; LE, 60
Interventional group, 59 years; control group, 62 years 61 years
Control group, 68.1; intervention group, 68.8 Intervention group, 63 years; control group, 64 years
Control group, 52.2; intervention group, 57.8 Not reported
Mean age in years
Not reported
Not reported
None
National Cancer Institute Not reported
Not reported
Not reported
15 days
Not reported
Not reported
Not reported Hamburg Cancer Society
Funding source(s)
79
Not reported
86 %
Not reported
Not reported
Not reported
Not reported
Not reported
No. of white participants (%)‡
Referred by attending physician
Referred by attending oncologist Not reported
Not reported
Approached by the project nures or medical doctor while still in the hospital. Some visited at home following discharge. Not Reported
Not reported Not reported
Recruitment method
42.9 % had 12 years
Not reported
12 years
Not reported
Not reported
Not reported
Not reported
Not reported
Education
Not reported
Not reported
Not reported Not reported
Mean time after diagnosis
36 %
17 %
27 %
35 %
26.23 %
51.40 %
57.14 %
Not reported
No. of female participants (%)‡
J Gastrointest Canc (2014) 45:181–189 183
Intervention type
Intervention type
Physical
Psychological
Psychological
Chemotherapy and supportive
Chemotherapy and supportive
Web-based collaborative care
Author, publication date, (reference)
Author, publication date, (reference)
Na, Kim, Kim, Ha, and Yoon, 2000 [12]
Kuchler, Bestmann, Rappat, Henne-Bruns, and Wood-Dauphinee, 2007 [15]
Ross, Thomsen, Karlsen, Boesen, and Johansen, 2005 [14]
Glimelius, Ekstrom, Hoffman, Graf, Sjoden, Haglund, Svensson, Enander, Linne, Sellstrom, and Heuman [18]
Cunningham, Pyhornen, James, Punt, Hickish, and Heikkila [19]
Steel, Kim, Geller, Marsh, Antoni, Dew, Schulz, and Tsung [17]
Table 1 (continued)
Outpatient, face to face, telephone, and Website
Outpatient face to face
Outpatient face to face
Outpatient face to face
Inpatient face to face
Inpatient face to face
Delivery format
Delivery format
6 months
Every 3 weeks until death or for at least 1 year
49 months
10 1-h sessions over 2-year period
Median length, 22 days; mean duration, 222 contact minutes
2 weeks
Intervention length
Intervention length
Individually tailored
Intervention group, visited in the home 5 times during first 2–3 months and then once approximately 4. 7, 11, 16, and 24 months after discharge. Control group, no intervention Intervention group, above age 60 given KPS 70 and sequential 5-FU and leucovorin (5-fluorouracil (500 mg/m2)/ leucovorin regimen (60 mg/m2) (FLv) given on 2 consecutive days every second week, below age 60 ELF-regimen (5-fluorouracil (500 mg/m2)/ leucovorin Intervention group, irinotecan 350 mg/m2 diluted in 250 mL normal saline or dextrose over a 90-min intravenous infusion every 3 weeks (or 300 mg/m2 if aged 70 years or under or WHO performance status 2) and best supportive care. Control Group, best supportive care
Intervention group, psychotherapist who gave educational information, a supportive relationship and ongoing, counseling to the patients at bedside. Control group, no psychotherapeutic counseling
Group 1, arm and bicycle ergometers 2×/day 5×/week at 60 % of maximal heart rate. Control group, no exercise
Total time or daily dose per intervention protocol*
Total time or daily dose per intervention protocol*
Enhanced usual care
Palliative nonchemotherapy support measures
Psychotherapist
Psychotherapist
Palliative nonchemotherapy and support measures
None
Project nurse or medical doctor
Not reported
None
None
Not reported
Psychotherapist
Control intervention
Control intervention
Type of therapist
Type of therapist
(1) Below 76 years of age; (2) surgically noncurable histologically verified gastric adenocarcinoma; (3) serum creatinine, >125 mmol/L; (4) serum bilirubin level, >60 mmol/L; (5) Karnofsky performance status (KPS), 125 mmol/L; (4) serum bilirubin level, >60 mmol/L; (5) Karnofsky performance status (KPS),
ORIGINAL RESEARCH
A Systematic Review of Randomized Controlled Trials Testing the Efficacy of Psychosocial Interventions for Gastrointestinal Cancers Jennifer L. Steel & Kathryn Bress & Lydia Popichak & Jonathan S. Evans & Alexandra Savkova & Michelle Biala & Josh Ordos & Brian I. Carr
Published online: 15 April 2014 # Springer Science+Business Media New York 2014
Abstract Introduction Psychological morbidity in those diagnosed with cancer has been shown to result in poorer quality of life and increase the risk of mortality. As a result, researchers have designed and tested psychosocial interventions to improve quality of life and survival of patients diagnosed with cancer. Methods A systematic review of the literature was performed to describe the psychosocial interventions that have been tested in patients with gastrointestinal cancers. Databases such as MEDLINE, PsychINFO, PubMed, MedLine, and Cochrane Reviews were searched. The searches were inclusive of studies published in English between 1966 and October 2013. Raters conducted full-text review of the resulting articles for the following eligibility criteria: (1) participants were 18 years or older, (2) the majority of patients in the sample were diagnosed with a gastrointestinal cancer, (3) the trial was testing a psychosocial intervention, and (4) random assignment to one or more interventions versus a usual care, placebo, attention control, or waiting-list control condition. Results The interventions that were eligible for this review included psychosocial or behavioral intervention (e.g., cognitive behavioral therapy, problem solving, educational, and collaborative care), physical activity, and/or psychopharmacologic treatment (e.g., selective serotonin reuptake inhibitor). Interventions that included dietary changes were not included in the present review. Study quality was also assessed using the Physiotherapy Evidence Database (PEDro) system. The results of the review resulted in a finding of eight studies to J. L. Steel (*) : K. Bress : L. Popichak : J. S. Evans : A. Savkova : M. Biala : J. Ordos Department of Surgery, University of Pittsburgh School of Medicine, 3459 Fifth Avenue; Montefiore 7S, Pittsburgh, PA 15213, USA e-mail: [email protected] B. I. Carr Liver Cancer Program, IRCCS de Bellis, Bari, Italy
have been conducted, testing psychosocial interventions, in patients with gastrointestinal cancers. Findings of these studies suggested that the interventions were effective in reducing psychological and physical symptoms associated with the cancer, improved quality of life, and reduced immune system dysregulation, and one study demonstrated an improvement in survival. Two studies reported no benefit from psychosocial intervention when compared with a control group. The quality of the studies varied greatly, but reporting of the details of the trials, and the methodological rigor, improved over time. Conclusion Further research is warranted to design and test interventions that may be effective in patients diagnosed with gastrointestinal cancers. Keywords Systematic review . Gastrointestinal cancers . Intervention . Psychosocial
Introduction Psychological morbidity has been shown to significantly reduce quality of life and even increase the risk of mortality in people diagnosed with cancer [1–3]. As a result, decades of research testing the effectiveness of psychosocial interventions to reduce psychological morbidity such as anxiety and depression, improve health behaviors, and overall quality of life have been conducted. Such a large body of research exists, in which several systematic reviews and meta-analyses have been performed to describe the overall findings of these studies [4, 5]. Overall, these interventions have been shown to reduce depression and anxiety and improve quality of life and immune system functioning [4, 6–9]. Interventions that were delivered individually and were longer in duration (>12 weeks) were found to be most effective [7].
182
One of the most controversial areas that continues to be debated is whether psychosocial interventions improve survival. Smedslund and Ringdal found mixed results with regard to the role of psychosocial interventions on survival [4]. Psychosocial interventions delivered to the individual, rather than in a group, were found to have significant improvements in survival [4]. Chow and colleagues [5] analyzed eight trials that assessed the efficacy of psychosocial interventions in improving survival. These researchers also found that the patients in the intervention arms of the studies had an improvement in survival when compared with those in the usual care arm [5]. Although these meta-analytic studies demonstrated that the psychosocial interventions were effective, the size of the effect was often small [4, 5]. Furthermore, research conducted examining the effectiveness of psychosocial interaction was unexclusive because the investigators included patients who did not have clinically significant symptoms [4, 5]. Hart and colleagues [10] demonstrated that studies testing the efficacy of psychosocial intervention, which screened for patients with clinical levels of depressive symptoms, had larger effect sizes. Despite the decades of research in testing psychosocial interventions to reduce psychological symptoms and improve quality of life and survival, few studies have been published that have tested the effectiveness of psychosocial interventions in patients diagnosed with gastrointestinal cancers. The aims of this systematic review were to provide a summary of the findings from studies that have targeted patients diagnosed with gastrointestinal cancers. Given the advanced stage in which many gastrointestinal cancers present and the importance of maintaining quality of life, the benefit of psychosocial interventions may be great for this patient population.
Methods Database Search For the purposes of this paper, gastrointestinal cancer included neoplasms of the stomach, colon, esophagus, liver, gallbladder, and bile ducts. We did not include mixed heterogeneous samples of cancer patients in this review unless the majority of the sample included gastrointestinal cancer patients. Databases were searched, including MEDLINE, PsycINFO, PubMed, MedLine, and Cochrane. The keyword searches used were: “psychosocial intervention,” “intervention,”,“psychological treatment,” and “cancer or neoplasm.” The search of studies was performed using a Boolean operator, “and” and “or”, limiting the search to randomized controlled studies. The searches were inclusive of studies published in English between 1966 and October 2013. We also examined the references of the articles identified through the searches, relevant reviews and meta-analyses.
J Gastrointest Canc (2014) 45:181–189
Inclusion Criteria Retrieved studies were independently assessed for relevance by two reviewers (SA and JS) and included if all of the inclusion criteria were met. Raters (SA and LP) conducted full-text review of the resulting articles for the following eligibility criteria: (1) adult participants (18 years or older) with a cancer diagnosis at the time of study entry; (2) inclusion criterion that included a trial testing a psychosocial intervention in a sample of gastrointestinal cancer patients; and (3) random assignment to one or more interventions versus a usual care, placebo, attention control, or waiting-list control condition. Interventions that were included in this review included psychosocial or behavioral intervention including psychotherapy (e.g., cognitive behavioral therapy, problem solving, educational, and collaborative care), physical activity, and/or psychopharmacologic treatment (e.g., selective serotonin reuptake inhibitor) and supportive care. Interventions that included dietary changes were not included in the present review. Data Extraction Predesigned tables were used to ensure that data extraction was standardized. Extracted information included: the number of individuals invited to participate, number of participants randomly assigned, demographic characteristics, cancer type, stage, setting, point in medical treatment, funding source, time since diagnosis, recruitment method, intervention type, delivery, duration, total dose of intervention, control arm, screening criterion, timing of assessment, and outcome type. Study Quality Studies were assessed for quality using the Physiotherapy Evidence Database (PEDro) scale which was designed to identify studies that are generalizable, internally valid, and Interpretable [11].
Results Gastrointestinal cancers are the subject of proportionally few cancer-related studies. A total of eight studies have been conducted with this patient population [12–19]. The intervention types include physical activity (n=2), psychosocial (n= 4), and supportive or palliative care (n=2). See Table 1 for details of the studies. The summary of the studies can be found below. Physical Activity Na and colleagues [12] examined the effect of an exercise intervention on natural killer cell cytotoxic activity (NKCA)
249 61
279
592 Not reported
Not reported
Inpatient
All stages UICC II or III
Heterogenous, majority of patients with GI cancer Colorectal
Steel, Kim, Geller, Marsh, Antoni, Dew, Schulz, and Tsung [17] Allgayer, Nicolaus, and Schreiber, 2004 [13] Steel, Nadeau, Olek, and Carr, 2007 [16] HCC, gallbladder, or cholangio
Outpatient
Not reported
Colorectal
Advanced cancer
Not reported
Outpatient
Outpatient
Outpatient
Outpatient
Inpatient Inpatient (95 %)
Not reported
Ross, Thomsen, Karlsen, Boesen, and Johansen, 2005 [14]
Not reported Not reported
Gastric adenocarcinoma
Inpatient or outpatient
Glimelius, Ekstrom, Hoffman, Graf, Sjoden, Haglund, Svensson, Enander, Linne, Sellstrom, and Heuman [18] Cunningham, Pyhornen, James, Punt, Hickish, and Heikkila [19]
Stage
14
Stomach Esophageal, stomach, liver/gallbladder, pancreas, colon, or rectal Colon
28
30
Not reported
Na, Kim, Kim, Ha, and Yoon, 2000 [12] Kuchler, Bestmann, Rappat, Henne-Bruns, and Wood-Dauphinee, 2007 [15]
23
Not reported
178
Cancer type
261
340
Not reported
Not reported
171
42
35
No. of participants postintervention
Author, publication date, (reference)
Steel, Kim, Geller, Marsh, Antoni, Dew, Schulz, and Tsung [17] Allgayer, Nicolaus, and Schreiber, 2004 [13] Steel, Nadeau, Olek, and Carr, 2007 [16]
272
705
Kuchler, Bestmann, Rappat, Henne-Bruns, and Wood-Dauphinee, 2007 [15] Ross, Thomsen, Karlsen, Boesen, and Johansen, 2005 [14] Glimelius, Ekstrom, Hoffman, Graf, Sjoden, Haglund, Svensson, Enander, Linne, Sellstrom, and Heuman [18] Cunningham, Pyhornen, James, Punt, Hickish, and Heikkila [19]
35
Not reported
Na, Kim, Kim, Ha, and Yoon, 2000 [12]
No. of patients randomly assigned
No. of individuals invited to participate
Author, publication date, (reference)
Table 1 Characteristics of studies
Newly diagnosed
Postprimary treatment
Postdiagnoses of metastatic colorectal cancer Newly diagnosed
Postdiagnosis of noncurable gastric adenocarcinoma
Postoperation
Postopeartive day 2 Pre- and postoperation
Point in medical treatment
67
ME group, 49; LE, 60
Interventional group, 59 years; control group, 62 years 61 years
Control group, 68.1; intervention group, 68.8 Intervention group, 63 years; control group, 64 years
Control group, 52.2; intervention group, 57.8 Not reported
Mean age in years
Not reported
Not reported
None
National Cancer Institute Not reported
Not reported
Not reported
15 days
Not reported
Not reported
Not reported Hamburg Cancer Society
Funding source(s)
79
Not reported
86 %
Not reported
Not reported
Not reported
Not reported
Not reported
No. of white participants (%)‡
Referred by attending physician
Referred by attending oncologist Not reported
Not reported
Approached by the project nures or medical doctor while still in the hospital. Some visited at home following discharge. Not Reported
Not reported Not reported
Recruitment method
42.9 % had 12 years
Not reported
12 years
Not reported
Not reported
Not reported
Not reported
Not reported
Education
Not reported
Not reported
Not reported Not reported
Mean time after diagnosis
36 %
17 %
27 %
35 %
26.23 %
51.40 %
57.14 %
Not reported
No. of female participants (%)‡
J Gastrointest Canc (2014) 45:181–189 183
Intervention type
Intervention type
Physical
Psychological
Psychological
Chemotherapy and supportive
Chemotherapy and supportive
Web-based collaborative care
Author, publication date, (reference)
Author, publication date, (reference)
Na, Kim, Kim, Ha, and Yoon, 2000 [12]
Kuchler, Bestmann, Rappat, Henne-Bruns, and Wood-Dauphinee, 2007 [15]
Ross, Thomsen, Karlsen, Boesen, and Johansen, 2005 [14]
Glimelius, Ekstrom, Hoffman, Graf, Sjoden, Haglund, Svensson, Enander, Linne, Sellstrom, and Heuman [18]
Cunningham, Pyhornen, James, Punt, Hickish, and Heikkila [19]
Steel, Kim, Geller, Marsh, Antoni, Dew, Schulz, and Tsung [17]
Table 1 (continued)
Outpatient, face to face, telephone, and Website
Outpatient face to face
Outpatient face to face
Outpatient face to face
Inpatient face to face
Inpatient face to face
Delivery format
Delivery format
6 months
Every 3 weeks until death or for at least 1 year
49 months
10 1-h sessions over 2-year period
Median length, 22 days; mean duration, 222 contact minutes
2 weeks
Intervention length
Intervention length
Individually tailored
Intervention group, visited in the home 5 times during first 2–3 months and then once approximately 4. 7, 11, 16, and 24 months after discharge. Control group, no intervention Intervention group, above age 60 given KPS 70 and sequential 5-FU and leucovorin (5-fluorouracil (500 mg/m2)/ leucovorin regimen (60 mg/m2) (FLv) given on 2 consecutive days every second week, below age 60 ELF-regimen (5-fluorouracil (500 mg/m2)/ leucovorin Intervention group, irinotecan 350 mg/m2 diluted in 250 mL normal saline or dextrose over a 90-min intravenous infusion every 3 weeks (or 300 mg/m2 if aged 70 years or under or WHO performance status 2) and best supportive care. Control Group, best supportive care
Intervention group, psychotherapist who gave educational information, a supportive relationship and ongoing, counseling to the patients at bedside. Control group, no psychotherapeutic counseling
Group 1, arm and bicycle ergometers 2×/day 5×/week at 60 % of maximal heart rate. Control group, no exercise
Total time or daily dose per intervention protocol*
Total time or daily dose per intervention protocol*
Enhanced usual care
Palliative nonchemotherapy support measures
Psychotherapist
Psychotherapist
Palliative nonchemotherapy and support measures
None
Project nurse or medical doctor
Not reported
None
None
Not reported
Psychotherapist
Control intervention
Control intervention
Type of therapist
Type of therapist
(1) Below 76 years of age; (2) surgically noncurable histologically verified gastric adenocarcinoma; (3) serum creatinine, >125 mmol/L; (4) serum bilirubin level, >60 mmol/L; (5) Karnofsky performance status (KPS), 125 mmol/L; (4) serum bilirubin level, >60 mmol/L; (5) Karnofsky performance status (KPS),
