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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05421884
Other study ID # STUDY00002262
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 3, 2022
Est. completion date September 30, 2022

Study information

Verified date June 2022
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date September 30, 2022
Est. primary completion date June 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
5 Love Languages
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).

Locations

Country Name City State
United States Texas Oncology Fort Worth Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain 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
Primary Depression 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
Primary Anxiety 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 Relationship Quality 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
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