None listed
Conditions
Brief summary
This study will test the efficacy of Coping-Together – a couple-based self-directed, coping skills training intervention. It is anticipated that using the proposed Coping-Together skills will be associated with couples experiencing less anxiety. Who is it for? You may be eligible for the study if you have recently been diagnosed with Stage I, II or III breast, prostate or colorectal (bowel) cancer, or melanoma and are currently receiving or planning to receive treatment. Your partner must also be willing to participate and you must both be able to understand and complete surveys. Trial details: You will be randomised to one of two treatment conditions, either the Coping-Together intervention or to the Minimal Ethical Care condition. The purpose of the study is to test the suitability of the information resources and assess which condition enhances illness adjustment and coping with cancer. All groups will be supplied with cancer and coping information, which participants work through at their own pace. What are you being asked to do? To participate in this study you will need to complete 4 surveys and receive an orientation call from research staff over a 6 month period. You are also asked to use the information resources provided as much as possible.
Interventions
Descriptions of intervention(s) / exposure: The intervention group receive a self-directed illness self-management and coping skills training intervention, Coping-Together that aims to provide couples with the resources they need to confront the challenges posed by a cancer diagnosis. A holistic foundation underpins Coping-Together, including strategies to manage physical, social, psychological and existential cancer-related challenges. The core component of Coping-Together is a series of 6 book
Descriptions of intervention(s) / exposure: The intervention group receive a self-directed illness self-management and coping skills training intervention, Coping-Together that aims to provide couples with the resources they need to confront the challenges posed by a cancer diagnosis. A holistic foundation underpins Coping-Together, including strategies to manage physical, social, psychological and existential cancer-related challenges. The core component of Coping-Together is a series of 6 booklets, each addressing one of the following challenges: 1) communicating with health care professionals, 2) making treatment-related decisions, 3) managing symptoms and side effects of treatment, 4) managing worries and emotions, 5) supporting your partner, and 6) accessing community support services. The Coping-Together booklets are complemented by multi-media resources, including a DVD, Relaxation CD and a website. The duration of the trial is 6 months, during which time participants (regardless of group allocation) will be asked to use the information resources they have been sent, complete follow-up surveys and participate in an orientation phone call/interview (duration approximately 5-10 minutes) to discuss their intended use of the resource material. The Coping-Together group also receives the Minimal Ethical Care control materials. In regards to resource use, couples are asked to use the resources as much as they can, however it is acknowledged that not all content will apply to every participant. It is therefore expected that the time spent using the intervention materials will vary from participant to participant.
Sponsors
University of New South Wales, Faculty of Medicine, South West Sydney Clinical School, CONCERT Translational Cancer Research Centre, Ingham Institute for Applied Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Diagnosed within the past 4 months with Stage I, II or III breast, prostate, or colorectal (bowel) cancer, or melanoma b) Receiving, or planning to receive treatment c) Partner willing to participate in the study d) Patient or partner scoring 4+ on the Distress Thermometer e) Sufficiently fluent in English and cognitively able to complete surveys.
Exclusion criteria
a)Identfied by health care professionals as not being well enough to participate in the study, which might include but is not limited to, concurrent psychiatric conditions. b) Patient previously diagnosed with cancer c) Partner not willing to participate
Outcome results
None listed