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Couple-based Interventions for Cancer (CCST2 Trial)
N/A
Recruiting
Led By Laura Porter, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of one the following advanced cancers: Stage IIIB or IV non-small cell lung cancer or extensive stage small cell lung cancer, Stage III pancreatic cancer or Stage IV GI cancer, Stage IV GU cancer, or Stage IV breast cancer.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Awards & highlights
CCST2 Trial Summary
This trial will evaluate whether a Couple Communication Skills Training intervention can help patients with advanced cancer and their spouses/intimate partners. 250 couples will be randomized to either receive the CCST or an attention control condition.
Who is the study for?
This trial is for couples where one partner has advanced cancer (specific types like certain stages of lung, pancreatic, GI, GU, or breast cancer) and they both speak English. They must be in a committed relationship and willing to discuss their feelings openly. Couples can't join if the patient's life expectancy is less than 6 months, either is too ill to participate or use a computer/videoconferencing.Check my eligibility
What is being tested?
The study tests Couple Communication Skills Training (CCST) against Healthy Living Information (HLI). It aims to see how CCST affects relationships and mental health in patients with advanced cancer and their partners. Participants are randomly placed into two groups: one receives CCST while the other gets HLI.See study design
What are the potential side effects?
Since this trial involves communication training and lifestyle information rather than medical treatments, there aren't typical side effects like those seen with drugs or surgery. However, discussing sensitive topics could potentially cause emotional discomfort.
CCST2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with an advanced stage of lung, pancreatic, GI, GU, or breast cancer.
CCST2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in partner relationship functioning
Changes in patient relationship functioning
Secondary outcome measures
Changes in partner psychological functioning
Changes in patient and partner psychological functioning
Changes in patient psychological functioning
CCST2 Trial Design
2Treatment groups
Experimental Treatment
Group I: Healthy Lifestyle InformaionExperimental Treatment1 Intervention
Healthy Lifestyle Information provides couples with health information relevant to cancer in a supportive environment. Sessions focus on the following topics: fatigue, sleep disturbance, nutrition, physical activity, survivorship care plans, and palliative care. Patients and partners are invited to discuss their experiences around the session topics with the therapist and ask questions about the information presented.
Group II: Couple Communication and SupportExperimental Treatment1 Intervention
CCST includes components to assist couples in communicating effectively, decreasing avoidance of important cancer-related issues, and providing each other with support. It includes training in skills for sharing one's thoughts and feelings and listening to one's partner and responding in a supportive manner, and joint problem solving. Participants will be asked to participate inactivities at home between sessions to strengthen skills acquisition.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,046 Total Patients Enrolled
Laura Porter, PhDPrincipal InvestigatorDuke
2 Previous Clinical Trials
105 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor believes you have less than 6 months to live.I am unable to participate in an interview or give informed consent due to a mental health condition.You or your partner have a score of 1.0 or higher on the Holding Back screen.I am married or in a committed relationship.I have been diagnosed with an advanced stage of lung, pancreatic, GI, GU, or breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Couple Communication and Support
- Group 2: Healthy Lifestyle Informaion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment quota for this experiment?
"Affirmative. As per the clinicaltrials.gov database, this medicinal experiment is presently recruiting participants. The trial was inaugurated on October 20th 2020 and has been modified as of November 14th 2022. 460 individuals are needed between one medical site to take part in the study."
Answered by AI
Is this investigation still open to participants?
"This clinical trial is actively recruiting, as indicated on the official page hosted by clinicialtrials.gov. It was originally posted in October of 2020 and last updated in November of 2022."
Answered by AI
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