Search strategy
A systematic and comprehensive search for literature that developed, adapted, or otherwise evaluated psychosocial or psychologically informed interventions for children with cancer and/or their caregivers in LMICs and resources rich developing countries will be carried out across four databases: PubMed, PsycINFO, CINAHL and Cochrane for published work and ProQuest database for unpublished grey literature.
The search will be restricted to the title field and no other restrictions will be applied. A review of published literature on similar topics has been carried out to identify appropriate search terms for psychosocial interventions in LMICs and developing resources rich countries. These search terms will be combined and connected with Boolean operators to run the searches (Appendix A for search terms list and search syntax).
Eligible countries on the other hand, include those classified by the World Bank as LMICs namely Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Azerbaijan, Bangladesh, Belarus Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, China, Colombia, Comoros, Congo, Costa Rica, Côte d'Ivoire, Cuba, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Haiti, Honduras, India, Indonesia, Iran, Iraq, Jamaica, Jordan, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Lebanon, Liberia, Libya, Macedonia (FYROM), Madagascar, Malaysia, Montenegro, Morocco, Mozambique, Myanmar (Burma), Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Palestine, Papua New Guinea, Paraguay, Peru, Philippines, Rwanda, Samoa, Sao Tome and Principe, Senegal, Serbia, Sierra Leone, Solomon Islands, Somalia, South Africa, Sri Lanka, Sudan, Suriname, Syria, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Tunisia, Türkiye, Turkmenistan, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia and Zimbabwe) or resource-rich developing country (Bahrain, Brunei, Guyana, Kuwait, North Korea, Oman, Qatar, Russian Federation, Saudi Arabia and United Arab Emirates).
Coding procedure
All search hits will be added to a reference manager software (EndNote v x9.3.3) where all duplicates will be deleted through the auto de-duplicate function of the software and will be followed by at least two authors screening titles and abstracts independently to screen out unrelated studies. Full text screening will then be carried out by all authors to identify studies that match our inclusion criteria. Next, data will be extracted by all authors on a pre-designed data extraction sheet, which will include study design and characteristics (such as recruitment strategy, location), sample characteristics (ages, parents, caregivers, or children), disease characteristics, intervention characteristics (aims, theoretical orientation, dosage), and outcomes against the pre-determined criteria (listed elsewhere). Lastly, reference lists of the included studies will be manually screened to identify additional studies that may have been missed by the systematic search and attempts to contact study authors will be made in case of missing data. Any ambiguity or disagreement over eligibility of studies will be resolved through discussions within the research team, and at least 25% of the included studies will be randomly reviewed by the PI to ensure fidelity to eligibility criteria and minimize risk of data extraction bias. Reasons for exclusion will be recorded. All extracted data will be made available publicly.
Study design and features
We will code for year of publication, sample size, recruitment strategy, type of control group, study design (Randomized Controlled Trial (RCT), longitudinal, cross sectional, academic study, or case study), country and continent.
Participant characteristics
We will code for age of patient, gender, targeted individual (patient, parent, siblings, or caregiver) and baseline morbidities.
Disease characteristics
We will code for disease type, disease stage, prognosis, intent of treatment, event free survival and disease-free survival.
Intervention components
We will code for the type of intervention (education, psychological, spiritual, group discussion or financial), qualification and training of the interventionist/intervention team, average time of intervention, number of intervention sessions, completion of intervention, compliance of participants, theoretical framework of intervention and mode of delivering intervention.
Outcome measures
We will code for physical health, mental health, treatment completion/abandonment, internalizing psychopathology, burnout and type of assessment tool (survey, screening or self-report) and we will avoid health care providers impressions as we focus on a patient and family framework.
Inclusion criteria
Publications will be considered for inclusion if: they were 1) psychosocial interventions, 2) provided to children with cancer (ages 0 to 18 years), their parents, their siblings, or their caregivers, 3) provided to survivors of childhood cancer, 4) involved children under treatment for at least six months or have received at least two sessions of chemotherapy, 5) provided in countries that are classified as LMICs or developing countries by the World Bank, 6) took place in multi-center or mixed-resource settings, 7) targeted symptom alleviation, psychosocial enhancement or prevention, 8) published as case reports, clinical trials, observational studies or longitudinal studies.
Study screening and selection
Duplicates will be deleted, and titles and abstracts of retrieved hits will be screened by two authors independently and full text articles and theses will be similarly assessed. Any disagreement will be resolved through discussion with all team members until a consensus is reached.
Data Synthesis and Analysis
Pooled effect size, ANOVAs, mediators, heterogeneity, and publication bias analyses will be performed via the Comprehensive Meta-Analysis software (CMA v2) while the quality of included studies will be assessed via the Cochrane software “ROB2” (see below) and the PRISMA guidelines will be followed throughout.
Primary outcomes will be assessed through a weighted random effect model to ensure generalizability of our study across future studies. Anxiety and depression, fatigue, distress, or burnout, quality of life, treatment completion or abandonment and pain reduction will be compared between control and intervention groups. We will aim at answering the following questions as the primary outcome of the study:
1. Are psychosocial interventions beneficial to children with cancer and their families/caregivers in LMIC’s and developing countries?
2. What is the impact of combining different elements of psychosocial interventions?
3. How is the impact of psychosocial care assessed in LMIC’s and developing countries?
The secondary outcomes will be extracted for a qualitative synthesis and include participant and intervention characteristics, theoretical grounding, and outcome measurements.