COMPLETED

Coping Together: Couple-based Interventions for Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of the proposed study is to evaluate the Couple Communication Skills Training (CCST) intervention in 250 patients with advanced cancer and their spouses/intimate partners. Couples will be randomized 1:1 to receive either the CCST or to an attention control condition (Healthy Living Information; HLI). We will evaluate CCST effects on a range of patient and partner relationship and psychological outcomes.

Official Title

Couple Communication Skills Training for Advanced Cancer

Quick Facts

Study Start:2020-10-20

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04590885

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Married or in a committed intimate relationship 2. 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, Stage IV breast cancer and GYN cancer Stage III-IV ovarian, IV uterine, IV cervical. 3. Both members of the couple must speak and read English. 4. Patient and/or partner scores \>=1.0 on the Holding Back screen.	1. Patient lacks capacity for interview (documented diagnosis of active psychosis or dementia) or is unable to provide informed consent as assessed by research staff. 2. Patient has a life expectancy \< 6 months as estimated by his/her treating oncologist. 3. Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing. 4. Patient or partner is too sick to participate, as judged by the oncologist or research staff.

Inclusion Criteria

Exclusion Criteria

1. Married or in a committed intimate relationship
2. 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, Stage IV breast cancer and GYN cancer Stage III-IV ovarian, IV uterine, IV cervical.
3. Both members of the couple must speak and read English.
4. Patient and/or partner scores \>=1.0 on the Holding Back screen.

1. Patient lacks capacity for interview (documented diagnosis of active psychosis or dementia) or is unable to provide informed consent as assessed by research staff.
2. Patient has a life expectancy \< 6 months as estimated by his/her treating oncologist.
3. Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing.
4. Patient or partner is too sick to participate, as judged by the oncologist or research staff.

Contacts and Locations

Principal Investigator

Laura Porter, PhD

PRINCIPAL_INVESTIGATOR

Duke

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27705

United States

Collaborators and Investigators

Sponsor: Duke University

Laura Porter, PhD, PRINCIPAL_INVESTIGATOR, Duke

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-20

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-10-20

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Advanced Cancer