Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema

NCT02453295 | Unknown

• 1 other identifier: HopePilot
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The specific objectives and research questions of the proposed study are:

1. 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).
2. 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

Keywords

Lymphedema; Arm Disability; Cancer Survivorship; Intervention

Outcome Measures

Primary Outcomes (4)

• Adjustment to illness as per the Meaning of Illness (MIQ) tracked at 5 timepoints over 16 weeks

  Factor II and IV: Factor II addresses loss, stress, and function. Factor IV addresses hope as well as positive attitude and motivation. These 2 factors will be used to screen participants prior to the study. The full version of the MIQ will be administered at all timepoints once the study begins, along with the other questionnaires.

  T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

• Level of hope as per the Herth Hope Index (HHI) tracked at 5 timepoints over 16 weeks

  12-item (4 point) Likert scale that delineates 3 factors of hope: a) temporality \& future, b) positive readiness \& expectancy, and c) interconnectedness.32 Summative scores range from 12-48, with a higher score denoting greater hope. The HHI was piloted in and deemed to be acceptable in S2. Participants encountered few difficulties with completion.

  T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

• Quality of life as per the Short Form 12, (SF-12) tracked at 5 timepoints over 16 weeks

  Quality of Life (QOL) scale that measures seven concepts, including physical functioning, role limitations due to health problems, and social functioning. It is a shorter but valid alternative to the SF 36 and includes psychological aspects of illness (e.g., feeling energetic) not addressed by other instruments but relevant to S1 and S2 participants

  T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

• Impact of lymphedema as per the Lymphedema Quality of Life (LYMQOL) tracked at 5 timepoints over 16 weeks

  Validated measure for the impact of UL/LL LE. The instrument includes 28 UL items and 27 LL items for LE. Importantly, questions address physical LE symptoms, emotional impact, and activities of daily living.

  T0 - beginning (3 days prior to 1st workshop); T1 - midpoint; T2 - endpoint (3 days following final workshop); T3 - 4 weeks post-intervention; T4 - 8 weeks post-intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Intervention Group

Comparison Group

NO INTERVENTION

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.

Interventions

Intervention Group BEHAVIORAL

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).

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: lead
• University of New Brunswick: collaborator
• McGill University: collaborator
• Horizon Health Network: collaborator
• New Brunswick Health Research Foundation: collaborator

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Chad Hammond, PhD

  University of Ottawa

  STUDY DIRECTOR

Central Study Contacts

Roanne Thomas, PhD

CONTACT

613-562-5800; roanne.thomas@uottawa.ca

Ryan Hamilton, PhD

CONTACT

(506) 453-5030; r.hamilton@unb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Canada Research Chair/Professor

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 25, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 25, 2015

Record last verified: 2015-05