NCT01785576

Brief Summary

The purpose of this study is to determine whether a brief couple-based supportive intervention effectively assists patients and their partners coping with the challenges of head and neck cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

2.6 years

First QC Date

February 5, 2013

Last Update Submit

July 19, 2019

Conditions

Head and Neck Cancer

Keywords

coupleshead and neck canceroncologyspousal support

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    6 months

Secondary Outcomes (1)

  • Spousal Support

    6 months

Study Arms (2)

Couple-Based CBT Intervention

EXPERIMENTAL

Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.

Behavioral: Couple-Based CBT Intervention

Treatment as Usual

NO INTERVENTION

The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.

Interventions

Couple-Based CBT InterventionBEHAVIORAL

Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.

Couple-Based CBT Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recently diagnosed with Head and Neck Cancer receiving chemotherapy and/or radiation therapy
  • No history of cancer within past 3 years (other than basal cell)
  • Living with partner in a committed relationship at least 6 months
  • Patient and partner speak and read English

You may not qualify if:

  • Serious cognitive or emotional issues that preclude full participation in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (1)

  • Gremore TM, Brockstein B, Porter LS, Brenner S, Benfield T, Baucom DH, Sher TG, Atkins D. Couple-based communication intervention for head and neck cancer: a randomized pilot trial. Support Care Cancer. 2021 Jun;29(6):3267-3275. doi: 10.1007/s00520-020-05848-5. Epub 2020 Oct 26.

    PMID: 33106976DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

  • Tina Gremore, PhD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Director, Research Compliance

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

US(1)