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Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema

NCT02453295 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-05-25

No results posted yet for this study

Summary

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

  • Mastectomy Related Lymphedema
  • Lymphedema of Upper Limb
  • Lymphedema of Lower Extremity

Interventions

BEHAVIORAL

Intervention Group

The IG will meet weekly for 2 hours for 8 weeks. Administration of questionnaires (Meaning of Illness, MIQ; Herth Hope Index, HHI; Short Form 12, SF-12; Lymphedema Quality of Life, LYMQOL) will be completed by phone at all timepoints. 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 as well as a Workshop Evaluation 2 days following the final workshop (T2).

Sponsors & Collaborators

  • University of New Brunswick

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • Horizon Health Network

    collaborator OTHER

  • New Brunswick Health Research Foundation

    collaborator OTHER

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Chad Hammond, PhD · University of Ottawa

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453295 on ClinicalTrials.gov