Improving Self-Management in Head and Neck Cancer

NCT02409485 | Completed DMC

• 3 other identifiers: GCO 12-1641R21CA178478H-48778
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

By teaching skills to improve the coordination of care and support in couples coping with head and neck cancer (HNC), this couple-based psychosocial intervention holds great promise for improving self-management, reducing costly hospitalizations and treatment interruptions, and improving both partners' quality of life. Home-based delivery will enhance future dissemination and outreach to those who do not have access to psychosocial services or live far away from their care centers. If found effective, the intervention may also have salutary downstream effects on the health and well-being of HNC patients and their partners.

Conditions

Head and Neck Cancer

Keywords

self-management; head and neck cancer; psychosocial intervention; couples

Outcome Measures

Primary Outcomes (2)

• Feasibility of the CST intervention as assessed by recruitment and retention rates

  recruitment and retention rates

  6 months

• Acceptability of the CST intervention as assessed by the program evaluation questionnaire

  satisfaction with the intervention by completing a program evaluation questionnaire developed by the study team that asks about perceived skills mastery and satisfaction with program content and logistics

  6 months

Secondary Outcomes (5)

• PROMIS short form anxiety and depression

  6 months

• Patient QOL measured by MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)

  6 months

• Partners QOL measured by Short Form 12 (SF12)

  6 months

• Short Form Dyadic Adjustment Scale (DAS7)

  6 months

• Healthcare utilization as assessed by number of hospitalizations and unplanned clinic visits

  6 months

Study Arms (2)

Couples Skill-Training (CST)

EXPERIMENTAL

CST provides education about acute and long-term side-effects of HNC and teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care; and, 3) strategies to improve communal coping and confidence in the ability to work as a team.

Behavioral: Couples Skill-Training (CST)

Usual Medical Care (UMC)

NO INTERVENTION

Patients receive standard symptom management education by their health care team.

Interventions

Couples Skill-Training (CST) BEHAVIORAL

Patients and partners each receive a workbook and 6 one-hour telephone sessions with a Masters level trained interventionist. Manual content is tailored based on role (patient or partner). Couples participate together via speaker phone for half the sessions and patients and partners receive separate (individual) intervention calls for the other half of the sessions.

Couples Skill-Training (CST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient is initiating radiotherapy for HNC
• patient has Karnofsky score \> 50 (ambulatory \& capable of self-care)
• patient lives with a partner (spouse/significant other - includes homo- and heterosexual couples)
• patient/partner is able to provide informed consent
• patient/partner is \> age 18.

You may not qualify if:

• patient has significant comorbidities (e.g., HIV, transplant), or another illness that may require hospitalization
• patient/partner cannot read or communicate using spoken English.
• individuals with diminished mental capacity
• prisoners
• pregnant women

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Hoda Badr, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: November 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: April 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)