Clinical Trial Finder

Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners

Study Purpose

This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in patients with stage III-IV cancer and their partners.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Yes

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months - Married or cohabiting with a significant other of either gender for more than one year - At the time of recruitment, a life expectancy of greater than 6 months and/or a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 - English speaking - No significant hearing impairment that would prevent participation in sessions - Live within a 1 hour commuting distance from Rutgers Cancer Institute of New Jersey

Exclusion Criteria:

- Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03112668

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Rutgers, The State University of New Jersey

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherNIH
Overall Status Not yet recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Malignant Female Reproductive System Neoplasm, Malignant Hepatobiliary Neoplasm, Partner, Stage III Breast Cancer, Stage III Cervical Cancer, Stage III Colorectal Cancer, Stage III Lung Cancer, Stage III Prostate Cancer, Stage III Skin Melanoma, Stage III Uterine Corpus Cancer, Stage IIIA Breast Cancer, Stage IIIA Cervical Cancer, Stage IIIA Colorectal Cancer, Stage IIIA Lung Carcinoma, Stage IIIA Skin Melanoma, Stage IIIA Uterine Corpus Cancer, Stage IIIB Breast Cancer, Stage IIIB Cervical Cancer, Stage IIIB Colorectal Cancer, Stage IIIB Lung Carcinoma, Stage IIIB Skin Melanoma, Stage IIIB Uterine Corpus Cancer, Stage IIIC Breast Cancer, Stage IIIC Colorectal Cancer, Stage IIIC Skin Melanoma, Stage IIIC Uterine Corpus Cancer, Stage IV Breast Cancer, Stage IV Cervical Cancer, Stage IV Colorectal Cancer, Stage IV Lung Cancer, Stage IV Prostate Cancer, Stage IV Skin Melanoma, Stage IV Uterine Corpus Cancer, Stage IVA Cervical Cancer, Stage IVA Colorectal Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Cervical Cancer, Stage IVB Colorectal Cancer, Stage IVB Uterine Corpus Cancer
Additional Details

PRIMARY OBJECTIVES:

  • I. To examine the feasibility and acceptability of couples' acceptance and commitment therapy (ACT) (C-ACT).
  • II. To collect pilot data on the impact of C-ACT on patients' and partners' anxiety, depression, and quality of life.
OUTLINE: Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session. After completion of the study, patients and their partners are followed up at 1 week.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

Site Contact

Sharon Manne

mannesl@cinj.rutgers.edu

732-235-6759

The content provided by NBTS on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Terms, Conditions & Privacy