Trial Title:
Short Questionnaire to Assess Individual Needs in Cancer Survivors in a Clinical Setting
NCT ID:
NCT06582498
Condition:
Cancer Survivors
Conditions: Keywords:
Cancer survivorship
Screener
Diet
Physical activity
Psychosocial distress
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A random allocation system will be applied to participants, which will be allocated to
the Low Intensity Intervention Group (LIIG) or the Active Intervention Group (AIG). Both
groups will attend a first, baseline visit offered to all participants with a trained
dietitian, who will administer the Life S-Can questionnaire and a series of validated
questionnaires. The LIIG will receive the standard care and recommendations already
provided by the Oncology Department of the hospital and a set of recommendations for
cancer prevention offered by the WCRF, the AICR and the ACS. The AIG will receive the
same recommendations as the LIIG and will be offered to see an oncological dietitian
(diet domain), a physical activity health professional (physical activity) and/or a
psychologist (psychosocial distress) for two visits (one individual, one group session).
All participants will attend a final visit after 3 months to collect data on feasibility,
acceptability and efficacy of the intervention.
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Active intervention
Description:
This group will receive a pamphlet with diet and lifestyle recommendations for cancer
survivors at randomization (2nd visit). Furthermore, they will be offered 3 individual
sessions with health professionals (oncological dietitian, sports therapist, and
oncological psychologist) and 3 group sessions with the same professionals. The duration
of the individual visits is expected to be 45-60 minutes approximately, and group
sessions will be planned for 1.5h duration approximately.
Arm group label:
Active intervention
Intervention type:
Behavioral
Intervention name:
Low-intensity intervention
Description:
This group will receive a pamphlet with diet and lifestyle recommendations for cancer
survivor at randomization (2nd visit). These recommendations are all based on information
from the World Cancer Research Fund, the American Institute for Cancer Research, and the
American Cancer Society.
Arm group label:
Low-intensity intervention
Summary:
The rate of cancer survivorship is increasing, posing the need to create high quality
survivorship care plans. Traditionally, follow-up of cancer survivors has focused on
detection of cancer recurrence or new cancers, but often it does not fully address
behavioural and psychosocial elements which could improve quality of life (QoL) and
potentially decrease recurrence risk. There is a current lack of short, validated
screeners to assess diet, lifestyle and other behaviours that might influence QoL and
prognosis in cancer survivors. The hypothesis of this project is that the creation of a
screener with the capacity to rapidly, validly and effectively assess nutritional
factors, lifestyle, sleep quality and psychosocial distress in cancer survivors could be
useful to identify individuals who may need further care and support. The aim is to
create a valid and rapid tool (Life S-Can) to evaluate a total of seven domains (body
composition, physical activity, diet, alcohol intake, smoking, sleeping behaviour and
psychosocial distress) in cancer survivors for its use in a clinical setting to improve
survivorship care and QoL. The project is divided into three phases and will be carried
out in one year at the University Hospital Son Espases (HUSE) (Palma, Spain). The
objective of Phase I is to design the screener, which will be administered to a small
convenience sample to determine comprehension, clarity and usefulness. In Phase II, Life
S-Can will be validated in cancer survivors (n=100) at HUSE and a pilot intervention will
be carried out with the objective to test the feasibility of a larger intervention to
effectively implement Life S-Can in clinical settings to improve QoL in cancer survivors.
For this, patients will be recruited by the Oncology Department and will be invited to
attend the Clinical Trials Unit for an exhaustive assessment. A research dietitian will
administer Life S-Can and will then collect data using validated questionnaires and
objective measurements to compare to the data obtained with the Life S-Can screener.
Participants will then be randomly allocated to either the Low Intensity Intervention
Group (LIIG) or Active Intervention Group (AIG). LIIG patients will receive standard care
and advice given to cancer survivors, and AIG patients will receive personalised feedback
(by means of individual and group sessions) in order to improve their body composition,
physical activity, diet, alcohol intake, and psychosocial elements based on their
answers, by trained professionals. Patients of both groups will also answer both Life
S-Can and validated questionnaires at baseline and after three months. Outcome
measurements will be indicators of feasibility (completion of questionnaires),
acceptability (by patients, health professionals), behavioural changes (diet, physical
activity, psychosocial distress) and QoL. Finally, Phase III consists of a qualitative
study conducted in cancer patients and health professionals to obtain data to design an
implementation study. Cancer survivors care should be multifactorial; however, often, due
to time constraints and clinical burden, health professionals might not assess certain
aspects relevant for cancer survivors' QoL, such as nutritional status, diet, physical
and mental health adequately. Life S-Can will enable clinicians, health practitioners,
charities and other stakeholders work with cancer survivors early-on and refer them to
adequate health and mental care teams and resources.
Detailed description:
The aim of this project is to develop a valid and rapid screening tool (Life S-Can) with
the capacity to evaluate a total of seven domains (body composition, physical activity,
diet, alcohol intake, smoking, sleeping behaviour and psychosocial distress) in cancer
survivors for its use in a clinical setting to improve survivorship care and QoL. The
project is divided into four specific aims (SA) and will be carried out in one year at
the University Hospital Son Espases (HUSE) (Palma, Spain).
SA1: Develop a short screener (Life S-Can) to evaluate body composition, physical
activity, diet, alcohol intake, smoking habits, sleeping behaviour and psychosocial
distress in cancer survivors.
SA2. Determine relative and construct validity of individual domains and total score of
the Life S-Can in cancer survivors using data obtained from validated and objective
measurements.
SA3. Carry out a pilot intervention study in cancer survivors to determine the
feasibility, acceptability and efficacy of Life S-Can.
SA4. Carry out a qualitative study in cancer survivors and health professionals to design
an implementation study.
The project herein presented proposes three phases: tool development (Phase I);
validation of the tool (Phase II - validation and pilot intervention study); and
qualitative (Phase III).
PHASE I: Phase I refers to SA1.
Recruit an expert panel: Together with the Principal Investigator, five key personnel
have been listed in this project, all of whom carry out research at the Health Research
Institute of the Balearic Islands (IdISBa, Spain) together with other duties (university
professor, medical doctor). Key personnel not contemplated as researchers in this project
include international experts in nutrition and cancer and will be consulted throughout
the project. Cancer survivors will also be contacted at this stage (through the hospital)
to involve them in the design stage.
Elements of the intervention at discussion: A series of meetings, semi-structured
interviews and panel groups will be planned with expert panel members and non-scientific
actors to define the best intervention. Elements to be defined during this stage are:
scoring of the individual domains of Life S-Can herein studied and traffic-light system
(good, intermediate and non-adherence, which will direct the intervention and health
professionals to be visited), monitoring of patients, pipeline, feedback, appointment
system, Clinical Trials Unit and data collection.
PHASE II:
Phase II consists of two objectives: a validation study (SA2) and a pilot intervention
study (SA3). The validation study will consist of three visits to the research/hospital
facility. The first visit will be at the Clinical Trials Unit, will take approximately 1
h and will be divided into three parts: 1) Administration of Life S-Can; 2)
Administration of validated questionnaires; and 3) Obtain objective measurements of the
patient. The second visit will also be at the Clinical Trials Unit and will take
approximately 10-15 minutes. Participants will be asked to return the accelerometer and
complete the Life S-Can questionnaire again (reproducibility). At this visit, patients
will be randomly allocated to the Low Intensity Intervention Group (LIIG) or Active
Intervention Group (AIG). The third and final visit will also be at the Clinical Trials
Unit and will take approximately 30 minutes. The participant will be asked to answer the
Life S-Can again, together with other questionnaires (QLQ-C30) and anthropometric
measurements, to measure changes in QoL.
The pilot intervention study (SA3) will be designed using a multi-disciplinary approach,
whereby knowledge and expertise in oncology, nutrition, epidemiology, psychology and
psychometry, validation and implementation will be called upon. In addition, the views
and experiences of cancer patients and patient organizations are essential in designing
an effective intervention; hence non-scientific authors will be contacted and included in
this phase.
This intervention phase is divided into three stages: intervention design, patient
recruitment and group allocation and intervention. Participation in this study will
entail visits to the Clinical Trials Unit at IdISBa, located within the Hospital
Universitari Son Espases. When possible, visits will be coordinated with other routine
appointments at the hospital in order to reduce as much as possible the burden on the
participant. Dietary, physical activity and psychologic interventions will be carried out
by in-house researchers (trained oncological dietitian) and external health
professionals.
Participants allocated to the LIIG will receive routine advice offered by their
oncological care team and a set of standard recommendations offered by the World Cancer
Research Fund, the American Institute for Cancer Research and the American Cancer
Society. Participants in the AIG will also receive this, and will also be offered the
chance to visit an oncological dietitian, a physical activity health professional and a
psychologist (one individual session, and one group session).
At the final visit, Life S-Can and QLQ-C30 questionnaires will be administered again in
order to determine any changes or impact on lifestyle and quality of life. Information
regarding feasibility and acceptability of the intervention will be collected from
participants.
PHASE III. The aim of the qualitative study is to design an implementation study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adults ≥ 18 years old; men & women; able to read and understand Spanish; prior
diagnosis of cancer (stages I to III); have completed all systemic treatment
(surgery, chemotherapy, radiation therapy) at least ≥3 months prior to the study
start date; be currently considered cancer free; able to attend visits at HUSE.
Exclusion Criteria:
- Ongoing cancer or cancer treatment; have a debilitating medical or psychiatric
illness; presenting a disorder that compromises comprehension (e.g., dementia);
pregnancy/breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fundació Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA)
Address:
City:
Palma De Mallorca
Zip:
07120
Country:
Spain
Start date:
September 2024
Completion date:
April 2025
Lead sponsor:
Agency:
Fundació d'investigació Sanitària de les Illes Balears
Agency class:
Other
Source:
Fundació d'investigació Sanitària de les Illes Balears
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06582498
https://www.wcrf.org/diet-activity-and-cancer/
https://www.nccn.org/patientresources/patient-resources
https://www.heart.org/en/healthy-living/healthy-lifestyle/lifes-essential-8
