- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05421884
Impact of Five Love Languages on Cancer Patients
June 13, 2022 updated by: Jennifer Hoang, University of Texas at Austin
The objective of this study is to evaluate the effectiveness of an intervention utilizing the Five Love Languages on quality of life (pain, depression, and anxiety) of cancer patients.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76104
- Texas Oncology
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients diagnosed with cancer with a significant other who attend a Texas Oncology couples support group will serve as the study population
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cancer Patient and their significant other
The intervention will implemented in all cancer patients and their significant others
|
Emotional support will be given through utilizing the patient/partners specific Love Language (physical touch, words of affirmation, gifts, quality time, and acts of service).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 6 weeks
|
Pain will be measured through the MD Anderson Cancer Center Brief Pain Inventory and improvement will be measured by change in pain scale score (ranging from 0=no pain to 10= pain as bad as you can imagine) from pre to post survey.
|
6 weeks
|
Depression
Time Frame: 6 weeks
|
Depression will be measured through the Patient Health Questionnaire (PHQ-9) scoring from 0 being not at all to 3 nearly every day of depression symptoms and improvement will be measured in by change in total scoring.
|
6 weeks
|
Anxiety
Time Frame: 6 weeks
|
Anxiety will be measured through the Generalized Anxiety Disorder 7-item (GAD-7) scoring from 0 being not at all to 3 nearly every day of anxiety symptoms and improvement will be measured in by change in total scoring.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship Quality
Time Frame: 6 weeks
|
This research study is also expected to measure improvement in the relationship of the cancer patient with their significant other.
This improvement in relationship will be measured through the Funk and Rogge Couples Satisfaction Index which contains various scales from 0-6 or 0-5 with lowest satisfaction being 0 and highest being 5/6 and improvement will be measured in change in score from pre to post survey.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (ACTUAL)
May 3, 2022
Primary Completion (ANTICIPATED)
June 14, 2022
Study Completion (ANTICIPATED)
September 30, 2022
Study Registration Dates
First Submitted
February 25, 2022
First Submitted That Met QC Criteria
June 13, 2022
First Posted (ACTUAL)
June 16, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 16, 2022
Last Update Submitted That Met QC Criteria
June 13, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00002262
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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