Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema
Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema
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.
This mixed methods pilot study builds on completed interviews with 13 participants in 2012
 (Study 1, S1) and delivery of a community-based intervention to 13 participants in 2013 (over
 2 days; Study 2, S2). The proposed research draws on these two studies, S1 (REB#H-05-12-04)
 and S2 (REB#H-05-12-04B), both of which were approved by the uOttawa REB. S2 included the
 same intervention as the one proposed herein, but in a compressed format. It was delivered in
 Ottawa, with positive feedback received from all 13 participants.

 Administration of the intervention will draw upon the team members' expertise (Hamilton,
 Hack) with interventions for people with cancer, a program of research in hope interventions,
 and Thomas' work with women with breast cancer related LE as well as S1 and S2. The
 intervention will follow a group-based workshop format. The intervention workshops will be
 offered weekly over 8 sessions (2 hours per session, one per week). After an introductory
 workshop, the second session will involve viewing the video, created by PI Thomas
 interviewing men and women who have lymphedema and group discussion of its themes, based on
 the principles of video modelling (e.g., how do participants' experiences, hope strategies
 compare?). This is an approach used successfully in other areas of research with marginalized
 peoples.

 Our program will follow Herth's theoretical foundations and goals (e.g., identifying support
 systems, developing plans to maintain hope in the future) along with established approaches
 to supportive care in chronic illnesses and LE international best practice guidelines.
 Briefly, workshops include modules addressing the building of a supportive community;
 orienting to hope and identifying threats to hope/coping; positive self-talk and
 affirmations; creative practices for exploring experiences and hope; and identifying and
 mobilizing resources. The modules also incorporate the completion and discussion of creative
 projects (e.g., writing exercises), mini-lectures by rehabilitation professionals, and SLC
 resources. All of these components were reviewed positively (satisfactory or above) by the
 majority of participants in S2. All activities are drawn from Herth's intervention, prior
 research, and the success of S2. This content was approved by the uOttawa REB, as noted
 previously. Four questionnaires administered to the IG/CG will be used to assess the
 potential impact of the intervention. Please see Study Protocol for summary of data
 collection.

 SUMMARY OF QUESTIONNAIRES

 1. The Meaning of Illness Questionnaire, (MIQ) 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.

 2. The Herth Hope Index (HHI) is a 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.

 3. Short Form 12, (SF-12): is a 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 ;

 4. Lymphedema Quality of Life, LYMQOL: is a validated measure for the impact of UL/LL LE.
 (110) 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.

 5. Demographic and Symptoms Questionnaire - contains 16 questions pertaining to age, family
 size, income and employment, and SLC symptoms. This questionnaire will only be
 administered at T0.

 DATA COLLECTION

 The IG will meet weekly for 2 hours for 8 weeks. All workshops will be recorded and
 transcribed, then analyzed qualitatively. The questionnaires (Meaning of Illness, MIQ; Herth
 Hope Index, HHI; Short Form 12, SF-12; Lymphedema Quality of Life, LYMQOL) will be
 administered by phone at the following timepoints: approximately 3 days prior to the first
 workshop (T0), between workshop 4 and 5 (T1) and approximately 3 days following the final
 workshop (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.

 For the Montreal site, the intervention (and post intervention data collection) will be
 administered by Chad Hammond (PhD, Psychology), a postdoctoral fellow who has worked
 extensively with cancer survivors. For Saint John, a qualified postdoctoral fellow will be
 hired by Co-PI Hamilton through the University of New Brunswick. Both will be trained by the
 Co-PIs.

 The CG will receive LE treatment as usual, without the hope intervention. Participants will
 be asked to refrain from joining similar, group-based workshops over the duration of the
 intervention. The measures will be administered the same questionnaires (by phone) as the IG
 at the same timepoints. Montreal and Saint John (ethics approval to be obtained from McGill
 U, UNB, and Health Horizon) has been selected for the current proposal as workshops were
 already completed in Ottawa (S2).

 At each site (Montreal and Saint John) potential participants (n=46) will be screened for
 eligibility based on Factors II and IV from the MIQ. The individuals scoring in the top ~30%
 (n=16) in terms of hope will be excluded from the study. The remaining 30 individuals scoring
 the lowest level of hope as per the MIQ will be admitted into the study. This initial
 appraisal will be brief, conducted over the phone, and therefore not too burdensome for
 potential participants. The investigators have chosen not to administer the full version of
 the MIQ (or other instruments) in order to screen efficiently and avoid potential practice
 and carryover effects in the administration of our other outcome measures. Towers (Montreal
 Co-I) and Tilley (Saint John Co-I) will approach potential participants in their LE clinics
 and their names/contact information will be forwarded to Dr. Chad Hammond, postdoctoral
 fellow (PDF) at the University of Ottawa for screening and randomization to the IG or CG.

 Questionnaires: S1 data and prior SLC research informs the selection of hope as the main
 outcome measure, using the HHI.

 EVALUATING THE INTERVENTION

 The impact of the intervention will be measured by assessing changes in outcomes over an
 2-month period. Questionnaires will be administered at intake (T0), midpoint (i.e., between
 workshop 4 and 5, T1), 3 days post-completion of the 8-week program (T2), 4 weeks
 post-intervention (T3), and 8 weeks post-intervention (T4). All participants will also
 complete a demographic questionnaire (T0), developed in S2. IG data will be collected via
 phone at all timepoints. A workshop evaluation form will also be administered to the IG at
 T2.

 CG data will be collected by phone at all timepoints (however, the workshop evaluation is
 irrelevant to the CG and will not be collected). The follow-up period is consistent with
 studies in systematic reviews and meta-analyses of psychosocial interventions for people with
 cancer. Participants who leave the study early will be asked to complete a telephone exit
 interview to explore and moderate completion (acceptability) issues for future programming
 and research. Notes from these interviews will be compiled as part of the assessment of
 feasibility.

 ASSESSING FEASIBILITY

 S2 used a convenience sample, with posters displayed in clinicians' offices. Based on this
 limited advertising and resulting timely accrual the investigators are confident that the
 investigators can achieve our target of 30 participants within 12 weeks as the investigators
 will be approaching SLC patients directly through 2 LE clinics (Montreal, QC and Saint John,
 NB). Using this screening measure, the investigators will endeavour to enroll equal numbers
 of men and women as well as those with UL/LL. The # approached, # meeting inclusion criteria,
 and reasons for declining will be documented. As this is a pilot, the investigators will
 proceed to the intervention phase whether or not the groups represent equal numbers of
 men/women and upper limb (UL)/lower limb (LL). However, data gathered will be used to inform
 adjustments that might be required for a future full trial. Consistent with RCTs and in
 preparation for a full trial, a participant flow diagram (# assessed for eligibility, #
 excluded, # refuse to participate, # randomized, # allocated to IG and CG, # lost to
 follow-up, # discontinued, # analyzed, # excluded from analysis) will summarize statistics
 for recruitment and retention. Participants will be considered to have left the intervention
 when they are absent from 25% (2/8) of the workshops and will be asked to complete a short
 exit interview by telephone.

 To assess the feasibility (and acceptability) of data collection, the investigators will
 address adherence to timepoints and barriers and facilitators to data collection. At the
 conclusion of the pilot, the impact of the intervention will be examined with an assessment
 of timeline data to determine whether all timepoints are feasible. If more than 50% of the
 sample requires more than 3 points of contact (phone and/or email) to schedule data
 collection, our team will modify the study design for a subsequent proposal (e.g., increase #
 of potential participants). Adherence to timepoint data will be generated through completion
 of a process log documenting dates of data collection for each participant as well as the #
 of points of contact required to schedule data collection. Descriptive statistics
 (frequencies, means, SD) will be generated to assess the feasibility of the timelines. Based
 on the data generated, timelines will be reviewed and adjusted if necessary before our
 subsequent CIHR proposal. Survey completion rates will be calculated, and % missing data will
 be noted. To provide additional data about acceptability, as in S2, IG participants will be
 encouraged to write notes on the hard copies of surveys (3 days prior Workshop 1 - T0;
 Intervention midpoint/between Workshop 4 and 5 - T1; Intervention completion/3 days following
 Week 8 - T2) to indicate any issues. These data will be transcribed, compiled, and analyzed.
 All of the above data will be triangulated to assess data collection feasibility.
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.