NCT05421884

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

February 25, 2022

Last Update Submit

June 13, 2022

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Relationship Quality

    6 weeks

Study Arms (1)

Cancer Patient and their significant other

EXPERIMENTAL

The intervention will implemented in all cancer patients and their significant others

Behavioral: 5 Love Languages

Interventions

5 Love LanguagesBEHAVIORAL

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).

Cancer Patient and their significant other

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with cancer with a significant other who attend a Texas Oncology couples support group will serve as the study population

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Oncology

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student Primary Investigator

Study Record Dates

First Submitted

February 25, 2022

First Posted

June 16, 2022

Study Start

May 3, 2022

Primary Completion

June 14, 2022

Study Completion

September 30, 2022

Last Updated

June 16, 2022

Record last verified: 2022-06

Locations

US(1)