A pilot, multisite, randomized controlled trial of a self-directed coping skills training intervention for couples facing prostate cancer: accrual, retention, and data collection issues
Purpose To examine the acceptability of the methods used to evaluate Coping-Together , one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. Methods Forty-two couples, randomized to a minimal ethical care (MEC) condition or to C...
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Published in | Supportive care in cancer Vol. 24; no. 2; pp. 711 - 722 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.02.2016
Springer Springer Nature B.V |
Subjects | |
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Abstract | Purpose
To examine the acceptability of the methods used to evaluate
Coping-Together
, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data.
Methods
Forty-two couples, randomized to a minimal ethical care (MEC) condition or to
Coping-Together
, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview.
Results
One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from
Coping-Together
. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of
Coping-Together
were noted for both patients and their partners.
Conclusions
This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies. |
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AbstractList | To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies. PURPOSETo examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data.METHODSForty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview.RESULTSOne hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners.CONCLUSIONSThis study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies. Purpose To examine the acceptability of the methods used to evaluate Coping-Together , one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. Methods Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together , completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. Results One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together . Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. Conclusions This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies. Purpose To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. Methods Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. Results One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. Conclusions This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies. To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies. |
Audience | Academic |
Author | McElduff, Patrick Lambert, Sylvie D. Girgis, Afaf Candler, Hayley Chong, Peter Turner, Jane Shih, Sophy T. F. Levesque, Janelle V. Regan, Tim W. Mihalopoulos, Cathrine Kayser, Karen |
Author_xml | – sequence: 1 givenname: Sylvie D. surname: Lambert fullname: Lambert, Sylvie D. email: Sylvie.lambert@mcgill.ca organization: Ingram School of Nursing, McGill University, Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales – sequence: 2 givenname: Patrick surname: McElduff fullname: McElduff, Patrick organization: School of Medicine and Public Health, The University of Newcastle – sequence: 3 givenname: Afaf surname: Girgis fullname: Girgis, Afaf organization: Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales – sequence: 4 givenname: Janelle V. surname: Levesque fullname: Levesque, Janelle V. organization: Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales – sequence: 5 givenname: Tim W. surname: Regan fullname: Regan, Tim W. organization: Priority Research Centre for Health Behaviour, The University of Newcastle – sequence: 6 givenname: Jane surname: Turner fullname: Turner, Jane organization: The University of Queensland – sequence: 7 givenname: Hayley surname: Candler fullname: Candler, Hayley organization: Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales – sequence: 8 givenname: Cathrine surname: Mihalopoulos fullname: Mihalopoulos, Cathrine organization: Deakin Health Economics, Faculty of Health, Deakin University – sequence: 9 givenname: Sophy T. F. surname: Shih fullname: Shih, Sophy T. F. organization: Deakin Health Economics, Faculty of Health, Deakin University – sequence: 10 givenname: Karen surname: Kayser fullname: Kayser, Karen organization: Kent School of Social Work, University of Louisville – sequence: 11 givenname: Peter surname: Chong fullname: Chong, Peter organization: Lake Macquarie Urology |
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To examine the acceptability of the methods used to evaluate
Coping-Together
, one of the first self-directed coping skill intervention for couples... To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing... Purpose To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples... PURPOSETo examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples... |
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SubjectTerms | Adaptation, Psychological Caregivers Clinical trials Couples Data collection Double-Blind Method Family Characteristics Humans Male Medicine Medicine & Public Health Middle Aged Nursing Nursing Research Oncology Original Article Pain Medicine Pilot Projects Prostate cancer Prostatic Neoplasms - psychology Prostatic Neoplasms - therapy Randomized Controlled Trials as Topic - ethics Randomized Controlled Trials as Topic - methods Rehabilitation Medicine Self Care - ethics Self Care - methods Studies Surveys Surveys and Questionnaires |
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Title | A pilot, multisite, randomized controlled trial of a self-directed coping skills training intervention for couples facing prostate cancer: accrual, retention, and data collection issues |
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