Head and Neck CancerCoupleCareNCT01785576
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
A study testing Couple-Based CBT Intervention in people with Head and Neck Cancer, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Couple-Based CBT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Serious cognitive or emotional issues that preclude full participation in study
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
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.
Read the detailed description
This intervention will adapt a well-validated cognitive-behavioral therapeutic approach in a four-session intervention to teach patients and partners specific couple-based cancer-focused support skills. In addition, in order to gather information on outcome variables, couples will complete three assessments during the course of treatment (pre-treatment, following treatment, and six month follow-up). These assessments will include questionnaire measures as well as couple communication whereby couples will participate in two videotaped conversations whereby one partner of the couple discusses a concern and the other member of the couple provides support. We also will implement a "daily diary" assessment whereby day-to-day psychological and physical symptoms experienced by the patient and partner will be assessed and daily effects of the intervention can be analyzed. Patients and partners will participate in the daily diary portion of the study following the post-assessment. They will be emailed an electronic link to a brief questionnaire daily for 7 days. The items in this daily assessment will comprise questions that are part of the general assessment measures such as dyadic coping, spousal support, and relationship satisfaction. The patient will also complete questions about pain and fatigue.
- Conditions
- Head and Neck Cancer
- Being tested
- Couple-Based CBT Intervention
- Keywords
- couples, head and neck cancer, oncology, spousal support
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-Based CBT InterventionBehavioural
Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: 6 months
Secondary outcomes (1)
Spousal Support
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Pulido, Endeavor Health
- Investigators
- Tina Gremore, PhD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785576
- Sponsor's protocol ID
- EH12-140
- Acronym
- CoupleCare
- Status last verified
- Jul 2019
- First submitted
- 5 Feb 2013
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33106976
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
- ClinicalTrials.gov ID
- NCT01785576
- Acronym / sponsor ID
- CoupleCare / EH12-140
- Conditions
- Head and Neck Cancer
- Keywords
- couples, head and neck cancer, oncology, spousal support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This intervention will adapt a well-validated cognitive-behavioral therapeutic approach in a four-session intervention to teach patients and partners specific couple-based cancer-focused support skills. In addition, in order to gather information on outcome variables, couples will complete three assessments during the course of treatment (pre-treatment, following treatment, and six month follow-up). These assessments will include questionnaire measures as well as couple communication whereby couples will participate in two videotaped conversations whereby one partner of the couple discusses a concern and the other member of the couple provides support. We also will implement a "daily diary" assessment whereby day-to-day psychological and physical symptoms experienced by the patient and partner will be assessed and daily effects of the intervention can be analyzed. Patients and partners will participate in the daily diary portion of the study following the post-assessment. They will be emailed an electronic link to a brief questionnaire daily for 7 days. The items in this daily assessment will comprise questions that are part of the general assessment measures such as dyadic coping, spousal support, and relationship satisfaction. The patient will also complete questions about pain and fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple-Based CBT Intervention | Experimental | Behavioral: Couple-Based CBT InterventionPatients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support. |
| Treatment as Usual | No intervention | –The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Serious cognitive or emotional issues that preclude full participation in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-Based CBT InterventionPatients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support. | Behavioural | Couple-Based CBT Intervention |
Primary outcome
Quality of Life
Time frame: 6 months
1 secondary outcome
Spousal Support
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 33106976Gremore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Gremore, PhD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-Based CBT Intervention in people with Head and Neck Cancer, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.