Clinical trial · Interventional

Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema

NCT02453295CI-TRIAL-00018012unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The specific objectives and research questions of the proposed study are: 1. a. Administer a group rehabilitation intervention to address loss and foster hope in 30 participants with upper and lower limb SLC --15 in an intervention group (IG), 15 in a control group (CG) at each of two research sites (Montreal, QC and Saint John, NB) for a total sample size of 60. Data about its impact will be collected by means of audiorecording 8 intervention workshops at each site and administering questionnaires (multiple timepoints). b. Test the intervention - Main hypothesis: The intervention group will show improvements in psychosocial well-being. 2. Assess feasibility (e.g., review our accrual strategies, randomization of participants, and data collection) via the completion of process logs.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphedema of Lower Extremity	—	UNRESOLVED	—
Lymphedema of Upper Limb	—	UNRESOLVED	—
Mastectomy Related Lymphedema	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Intervention Group	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Intervention Group
description
The IG will meet weekly for 2 hours for 8 weeks. All workshops will be recorded and transcribed, then analyzed qualitatively. Administration of questionnaires (Meaning of Illness, MIQ; Herth Hope Index, HHI; Short Form 12, SF-12; Lymphedema Quality of Life, LYMQOL) will take place over the phone. The questionnaires will be administered 3 days prior to workshop 1 (T0), between workshop 4 and 5 (T1), and 3 days following the completion of the intervention (T2). The questionnaires will also be administered at 4 weeks post-intervention (T3) and 8 weeks (T4) post-intervention. All participants will also complete a demographic questionnaire at T0, developed in S2.
interventionNames
1. Behavioral: Intervention Group
type
NO_INTERVENTION
label
Comparison Group
description
The CG will receive LE treatment as usual, without the hope intervention. They will be administered the same questionnaires (by phone) as the IG at the same timepoints. Potential participants (n=46) will be screened based MIQ. The individuals scoring in the top \~30% (n=16) will be excluded from the study. The remaining 30 individuals scoring the lowest level of hope will be admitted into the study.

Primary outcomes (4)

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion:

* men and women who are 18 years of age or older;
* who have been diagnosed with UL or LL SLC a minimum of 3 months prior to data collection;
* who are in the management phase of SLC treatment at the time of enrolment;
* are English speaking;
* are able to consent.

Exclusion:

* being in the active phase of LE treatment. Because this type of acute care involves intensive and time-consuming treatment, which would make participation in the proposed research extremely challenging, we will enroll only men and women who are in the management phase of treatment.
* non-English speaking. Non-English speaking participants will be excluded given time and resource constraints. In our recent qualitative study of SLC, no non-English speaking potential participants from Ottawa expressed an interest in the study. Future research (to expand the pilot intervention, if successful) will be bilingual.
* As noted previously individuals scoring in the top \~30% (n=16) in terms of hope according to the MIQ, will be excluded from the study.

References

Publications (0)

Data not yet available

No reference posted for this study.