|Grant Number:||5R03CA086614-02 Interpret this number|
|Primary Investigator:||Shields, Cleveland|
|Organization:||University Of Rochester|
|Project Title:||Coping with Cancer-Pilot Intervention with Couples|
The purpose of this research project is to develop, standardize, and pilot an intervention for couples coping with cancer. No studies have examined interventions designed to improve relationship functioning for couples as a means to help patients and spouses cope better with the cancer and its treatment. This study is based on this premise -- if couples' relationship functioning is improved then both patient and spouse will experience greater relationship satisfaction, less psychological distress, greater psychological well-being, and greater cancer-related quality of life. The specific aims of this study are: Aim 1 to generate an attachment-based intervention for distressed couples coping with cancer Aim 2 to standardize the couples' intervention by developing a manual, measures of therapists' adherence and competence, and a training program Aim 3 to conduct a pilot study of this intervention approach that will yield information essential for planning a randomized clinical trial of the couples' intervention. Design and Methods: This is a pilot study to develop a new behavioral treatment, it is akin to a Phase I study of a new drug. For Aim 1 the PI and other investigators will conduct focus groups generate ideas for interventions from cancer survivors. They will also conduct 3 pre-pilot intervention groups for couples coping with cancer to further develop the intervention protocol. They have written a preliminary treatment manual for the couples' intervention. The intervention, which targets cognitive aspects of attachment and behavioral aspects of communication, consists of 6 group sessions of 2 hours each. For Aim 2 the investigators will revise and update the treatment manual, develop instruments to assess therapist adherence to the treatment protocol, and develop a program to train therapists to conduct the intervention groups. For Aim 3 they will train therapists to conduct the treatment, test them on their knowledge of the treatment model, and supervise them as they conduct 7 pilot intervention groups. All couples participating in the intervention will be assessed prior to the first session; at the completion of the intervention; and at 3, 6, 9, and 12 month follow-ups. This study will yield important scientific and clinical information needed to further develop and test behavioral interventions for couples through randomized trials. First, this study will yield a manualized treatment protocol. Second, it will yield information on treatment effect sizes, which is essential for planning a randomized trial. Third, it will yield information on changes in mediating and moderating variables, which provides a test of the theory behind the intervention.