Cultural Adaptation Process of Cancer-Related Interventions: A Step-by-Step Guide

INTRODUCTION

To contribute to the reduction and elimination of cancer-related local and global health disparities, interventions must reach diverse cultural groups and demonstrate success in improving clinical and psychosocial outcomes. One approach to developing such interventions is to culturally adapt original evidence-based interventions to make them effective for a new cultural group. Cultural adaptation (CA) has been defined as the systematic modification of an intervention to consider language, culture, and context in a way that it is compatible with the individuals‘ cultural patterns, meanings, and values.¹ Metanalytic reviews conducted primarily with mental health interventions have shown that culturally adapted interventions are far more effective than non-adapted interventions for ethnic minority patients.^2,3 However, very few interventions have been adapted, piloted, and tested in the context of cancer (see appendix 2). Given the need to culturally adapt interventions and provide an evidence-base for its justification and implementation we provide step-by-step information on issues related to culturally adapting interventions.

Researchers in our group have adapted several interventions for Latino and Chinese patients, and we have developed a CA step-by-step guide that integrates the ecological validity model (EVM),¹ cultural adaptation process model (CAPM),⁴ and heuristic model for cultural adaptation (HMCA) proposed by Barrera and colleagues.⁵ The EVM addresses 7 dimensions of CA: language, context, persons, metaphors, concepts, goals, and methods.⁶ The CAPM is a complementary process model to the EVM and prescribes 3 phases for the adaptation process: formative, adaptation iterations, and intervention and measurement adaptation.⁴ The HMCA is based on a review of literature and integrates several adaptation process frameworks,⁵ recommending a five-phase approach: 1) information gathering, 2) preliminary adaptation design, 3) preliminary adaptation tests, 4) adaptation refinement, and 5) CA trial. A comparison of the three frameworks and their correspondence with the proposed phases and examples are described on Table 1.

Table 1.

Multistep cultural adaptation step-by-step for interventions in oncology with examples of adaptations conducted by the authors (Appendix 1) and described in the literature (Appendix 2)

Proposed Phases	Cultural Adaptation Process Model (Domenech and colleagues4)	Heuristic Model for Cultural Adaptation (Barrera and colleagues5)
Stage 1: Formative Research - Background (Phases 1-5)	The Background phase includes four steps: (1) a collaborative relationship is forged between the treatment developer and the cultural adaptation specialist (CAS), (2) the CAS examines the fit of the intervention with relevant literature, (3) the CAS meets key community leaders to examine interest and needs, and (4) the CAS conducts a needs assessment and gathers information to inform adaptations to the intervention.	Phase 1: Information gathering. This is done by conducting an initial literature review and a needs assessment with the target audience and stakeholders using quantitative and qualitative approaches.
Phase 1: Collaborative Relationships are forged	The treatment developer and the CAS should be engaged in a professional collaboration whereby mutual goals are stated overtly, and goals are articulated clearly. The treatment developer can provide formal training on the intervention, with emphasis on developing technical expertise, conceptual understanding, and important intervention process skills.	During the information gathering, it is valuable to establish an organized and systematic partnership, a team approach that integrates the concerns of relevant stakeholders: intervention program developers, agency administrators, program staff, community members, and others interested in program adaptation. This enhances a program’s effectiveness in serving the needs of a local constituency.
Examples: In all the field examples described, the adaptation specialists (authors Costas-Muniz, Torres-Blanco, Lui) established a collaborative relationship with the intervention developers and received training in the original intervention (Appendix 1). Other examples (Appendix 2) of using an interprofessional team for intervention adaptation include the Puente para Cuidar, electronic Surviving Cancer Competently Intervention Program, and ADAPt-C studies.
Phase 2: Fit of the intervention with relevant literature	The CAS and team should review the literature to examine fit of the intervention with the state-of-the knowledge in the field, covering the areas of cultural adaptation, cancer-related research, patient-, family-, and caregiver-centered research, as pertinent, and treatment outcomes with Latino populations, among others.	The need to plan the adaptation should consider: (a) engagement, (b) action theory, the ability of treatments to change mediating variables, and (c) conceptual theory, the relations between mediators and outcomes. A robust literature review provides information about this preliminary step of cultural adaptation.
Examples: Field example 1 (Appendix 1): the investigators conducted a review of the literature and also initiated an observational study to determine the relations between mediators and outcomes. Field example 3 (Appendix 1): an extensive literature review supported the adaptation and integration of two evidence-based interventions. Literature example (Appendix 2): the adaptation of the interventions Puente para Cuidar, ADAPt-C, and FOCUS seemed to be primarily supported by literature reviews.
Phase 3: Stakeholders’ feedback about interest and needs Intervention manual and materials are translated	In this phase, the objective is to obtain initial feedback from the stakeholders. Domenech et al4 describe how the CAS should collaborate with community stakeholders to assess interest and acceptability.	As previously described, Barrera et al5 include in the information-gathering step activities related to conducting needs assessments with the target audience (i.e., patients, community members) and stakeholders (i.e., professionals, administrative personnel, community leaders) using quantitative (i.e., surveys) and qualitative (i.e., interviews) approaches.
Examples: All the field examples (Appendix 1, examples 1-4) provide information about receiving initial feedback from stakeholders that informed intervention adaptation. In the examples from the literature (Appendix 2), the Puente para Cuidar study team based their adaptations on discussions and reviews by the interprofessional study team using the ecological validity model (EVM) to identify needed adaptations. For the CASCADe intervention, a panel of 10 experts with expertise in translation, editing, and psychology translated and adapted the intervention using the EVM. Then, six experts were asked to evaluate the pertinence, language, and content validity of the adapted manual. In the Stronger Together Peer Mentoring Program, the authors reported that a diverse team of public health and oncology experts, patient advocates, and local stakeholders, including representatives from the Vietnamese Ministry of Health and National Cancer Institute, and administrators, head nurses, and social workers participated in the adaptation, addressing cultural characteristics (cognitive, affective, and environmental) in the adaptation of the program content, delivery, delivery person(s), delivery channel, and delivery location.
Phase 4: Needs assessment and information gathered for the adaptations Deliverable is a cultural adaption blueprint with proposed adaptations	The objective of this phase is to obtain feedback about proposed modifications to inform the adaptation. In this step, the CAS assesses the community needs while evaluating possible adaptations to the intervention. Further, based on the findings, the CAS, intervention developer, and team tailor the intervention.	For the preliminary adaptation design, ideas that are gathered during the first stage are then developed into a draft treatment adaptation. This is another opportunity to use qualitative research to gather opinions from potential participants and community experts on draft materials and descriptions of intervention activities.
Examples: All of the field examples (Appendix 1, examples 1-4) provide information about receiving feedback from recipients and experts about the proposed intervention adaptations and/or adapted manual. In examples from the literature (Appendix 2), several interventions (WeCOPE, Conexiones program, Cancer Transitions: Moving Beyond Treatment, and electronic Surviving Cancer Competently Intervention Program) used interviews and/or focus groups to develop and provide feedback on intervention acceptability. For the Cancer Transitions: Moving Beyond Treatment intervention, the study team conducted focus groups to obtain initial feedback (Phase 3), followed by focus groups to obtain feedback on the adapted intervention (Phase 4). For the electronic Surviving Cancer Competently Intervention Program, in the first phase, the intervention was translated and reviewed by Spanish-speaking members of the study team, consultants, and medical interpreters. The second and third phases included evaluation by participants and used Think Aloud Testing to refine the materials.
Phase 5: Selection of measures, validation, and/or adaptation	Domenech and colleagues4 state that in the measurement area, the CAS selects and reviews the measures for appropriateness of use with the intervention participants. Two indicators are used for measurement selection. First, measures should be sensitive to intervention-related change based on prior studies, and second, they should be available in the relevant language and validated for the target audience.	During the preliminary adaptation tests, the team should select culturally relevant measures, or translate and validate the needed measures, using evidence-based procedures.
Examples: All of the field examples (Appendix 1, examples 1-4) provide information about selecting instruments that were validated for the target population. For field example 2, EMPOWER-L, one instrument was concurrently adapted and validated by colleagues in Mexico.
Stage 2: Piloting Phase 6: Preliminary adaptation tests Address interventionist training Assess feasibility and acceptability	The third phase of the CAPM4 encompasses activities during the intervention trials in which adaptation is iterative. The pilot tests should test the feasibility of the adapted intervention implementation and data collection procedures. .	At this stage, investigators conduct case studies, or pilot studies with small groups. Participants should complete quantitative measures and could be interviewed to determine whether the goals of adaptation were met, to identify and discuss sources of program nonfit, implementation difficulties, or difficulties with program content or activities.
Examples: The interventions described in field examples 1 and 4 were being piloted (Appendix 1). In examples from the literature (Appendix 2), the following interventions included small pilots with 9-14 participants to understand and improve the feasibility of the adapted intervention: Puente para Cuidar, educational and skills-training parental intervention, and tailored cognitive behavioral therapy (CBT) for Mexican terminal cancer patients. For the culturally tailored lifestyle intervention for African American men with prostate cancer and partners, the adaptation plan included six steps: 1) organizational capacity, needs assessment, and logic model, 2) search for evidence-based interventions, 3) assess fit and plan adaptations, 4) adaptations made, 5) plan for implementation, and 6) plan for evaluation. The authors reported in the article that the intervention pilot was currently underway to determine feasibility by assessing enrollment, adherence, and retention success.
Phase 7: Adaptation refinement	The intervention adaptations are captured in the new version of the treatment manual, and the CAS consults with the treatment developer regarding possible decentering (making changes in the original intervention based on the information obtained during the adaptation).	Experience with pilot studies informs a revision of the intervention procedures. Evaluations of refined adaptations could include in-depth interviews with participants and interventionists to inform further modifications.
Stage 3, Phase 8: Intervention trial	The team plans and implements replication and further field testing of the measures and the adapted intervention.	The adapted intervention can be evaluated with a research design that is capable of determining whether the adaptations had the desired effects at the engagement, action theory, or conceptual theory levels.
Examples: In Appendix 2, the project CARE and Encuentros de Salud were being tested in an efficacy trial. The project CARE intervention adaptation included research activities in the 8 proposed phases including a needs assessment, a focus group of members of the target community, a focus group with stakeholders, an iterative process of manual adaptation, pilot testing with a small group of participants, and a large-scale controlled clinical trial. The Encuentros de Salud study team also followed a systematic approach to culturally adapt the intervention in four stages, and they completed activities in the proposed phases including: (a) information gathering (e.g., review of the literature on cultural values, traditions, illness perceptions specific to Hispanics and cultural influences on core intervention components); (b) preliminary adaptation design (e.g., integrate input of key stakeholders and a community advisory board that had input from patients, health care providers and administrators in our Hispanic communities with 5 individuals from each city, forward/backward translation of language); (c) preliminary adaptation tests (e.g., train facilitators, pilot adapted intervention); and (d) adaptation refinement based on feedback from participants of a pilot trial of the intervention. The intervention was currently being tested in a RCT when the authors published the article.

Note. Originally, CAPM guided the intervention adaptation process conducted by the research teams; but the Heuristic Model for Cultural Adaptation was added as a guiding framework because it expands on issues pertaining pilot study design, methodological considerations, and implementation issues. However, CAMP still provides more information about the initial phases (prior to piloting). We consider the frameworks complement each other. Finally, these process frameworks are complemented by the Ecological Validity Model, a model that provides information about what dimension and/or areas of an intervention program need adaptation.

We provide step-by-step information on the conceptual and methodological challenges involved in culturally adapting interventions and provide guidelines, suggestions, tools, and concrete steps for implementing the process. We describe an intervention adaptation process guided by established CA frameworks and provide field examples (Table 1 and Appendices 1 and 2).

METHODS

Stage 1: Information Gathering

According to the HMCA,⁵ in the first information-gathering phase, the team determines whether an adaptation is justified and which intervention components to modify. Barrera and colleagues⁵ state that the justification to adapt should be determined based on differences in engagement (ability of procedures to reach potential participants and involve them successfully in the intervention) and/or outcomes (ability of the intervention to change the targeted variables). Similarly, Domenech et al⁴ divide Phase 1 (Background) into four steps. Formative studies need to be conducted to determine how the intervention would fit the needs and preferences of a subcultural group. During this stage, qualitative and quantitative studies can be conducted to inform the CA. The primary target of adaptation is usually the intervention manual, but the adaptation approach could also include patient-facing materials, intervention processes, research processes, instruments/measures, and study staff training materials.

Phase 1: Collaborative Relationships

Collaborative relationships are forged between the treatment developer and the CAS who will lead the research activities. A steering group is recommended, comprising a range of stakeholders/experts: a language/cultural expert (i.e., professional with expertise in language, cultural studies, minority health); community partners (i.e., community leaders, advocates, leaders of cancer patient groups/organizations); and professionals with content expertise (i.e., palliative care, etc.) and/or cultural expertise (i.e., cultural and linguistic background, etc.). Bilingual and/or bicultural staff may be needed, including research assistants, interventionists, community health workers, etc.

Phase 2: Fit of the intervention with relevant literature

The original evidence-based intervention literature⁷ and other pertinent literature needs to be examined with attention to sample characteristics, program delivery staff, and administrative/ community factors. Intervention needs must be discussed with the stakeholders (see Step 1).

Phase 3: Stakeholders’ feedback about interest and needs

Initial feedback from the stakeholders can be obtained through 1) advisory/steering committee meetings to elicit the interests and needs of patients, community members, and/or target audience; 2) stakeholder surveys; and/or 3) interviews or focus groups. Our initial needs assessments have been guided by the EVM, with attention to the dimensions of goals, concepts, and strategies. The team should 1) translate the goals/objectives, general description of the intervention, and main concepts; 2) inquire about appropriateness (with the target audience) and cultural acceptability of the intervention goals/objectives and concepts; and 3) inquire about the feasibility of the intervention (and study’s) strategies. Feasibility should include questions about recruitment, retention, delivery modes (i.e., in person, remote, etc.), and intervention structure (i.e., length, frequency of contact, etc.). Mixed methods (assessments that include quantitative: structured assessment or survey, and qualitative assessments: interviews, focus groups) can be combined to elicit more information and achieved triangulation.

Phase 4: Needs assessment and information gathered for the adaptations

This step can be conducted concurrently with Phase 3 or conducted afterwards, to obtain feedback about the proposed modifications. If needed, the intervention manual should be translated by translators who are familiar with medical and psychosocial terms. Following the EVM (Table 1), in several of our research studies, we ask questions about appropriateness/pertinence, cultural acceptability, and comprehensibility of goals, concepts, strategies, content, and metaphors, as well as feasibility of strategies and contextual issues (implementation barriers and facilitators). Mixed methods should be used with different stakeholders (patients/community members and professionals with content and/or cultural expertise). The data collected using mixed methods are then reviewed, synthesized, and discussed with the study team and steering committee while proposing adaptations to address the feedback obtained.

The deliverable of these adaptation meetings should be a CA blueprint with general proposed adaptations (additions, deletions, modifications), and specific proposed adaptations for each section of the manual, changes to goals, format, structure of the intervention, and measures and/or outcomes.

Information gathered in the previous steps is integrated to inform preliminary modifications of the original intervention. The intervention manual and study operations manual/protocol are reviewed and modified according to the blueprint. It is also recommended to use a framework, such as FRAME, to report adaptations and modifications to the evidence-based intervention.⁸

Phase 5: Selection of measures/validation/adaptation

Outcome measures are identified and/or validated. We either select measures that have been validated in the target language or, if those are unavailable, the study team translates and validates the cultural and linguistic adaptation of the instruments used with the original evidenced-based intervention. Guidelines and recommendations⁹ are proposed for the validation of instruments for different languages/cultures. If needed, the study team should engage in the development of instruments to measure the intervention outcomes. Also, other measures, like process evaluation measures and interview guides must be reviewed and adapted for the target population.

Stage 2: Piloting

Phase 6: Preliminary adaptation tests

After drafting a preliminary version of a CA, a pilot feasibility trial is recommended. Continuous feedback from study team members and interventionists is critical. The pilot feasibility trial should collect data about feasibility of recruitment, retention, attrition, training needs of the interventionists, preliminary efficacy of the intervention, target audience acceptability, and other pertinent process evaluation measures. Guidelines have been developed to guide the designs and execution of pilot trials.¹⁰ Fidelity assessments can be informative, facilitating analysis of common deviations and field modifications and indicating additional adaptations that might be required.¹¹ Exit interviews can also be informative about acceptability of the intervention content and feasibility of the strategies.

Phase 7: Adaptation refinement

Information from the interventionist training, recruitment/attrition trackers, fidelity assessments, and exit interviews is reviewed, tracked, synthesized, and discussed with members from the study team and steering committee. Feedback from the pilot is used to refine the adapted intervention.

Stage 3, Phase 8: CA trial

An empirical trial of the CA is conducted. For intervention delivery in low resource settings, pragmatic designs are encouraged. Pragmatic trials mimic usual clinical practice, and they are critical to inform decision-making by patients, clinicians, and policymakers in real-world settings (examples in Table 1, Appendices 1 and 2).¹²

DISCUSSION

CA of interventions in oncology settings are needed to maximize their potential and relevance for diverse cultural groups and to ultimately decrease health disparities. Researchers conducting CA face the challenge of retaining the singularities of each culture while producing an adapted intervention that aims to be equivalent, or as similar as possible in its goals and objectives, to the original evidence-based intervention, thus retaining cross-cultural applicability.

Clinical Implications

This manuscript provides information, guidelines, suggestions, tools, and concrete steps for implementing this process, followed with examples from the field, for researchers and CASs to be aware of the conceptual and methodological challenges involved in culturally adapting interventions. Our systematic step-by-step approach aims to improve the validity and rigor of cultural adaptation methodological approaches by recommending 1) the guidance of well-established research models; 2) use of multiple data sources and input from various stakeholders (i.e., from patients and providers); 3) qualitative and quantitative data usage and integration; 4) a steering committee with multiple perspectives, stakeholders assessments, and qualitative analyses; 5) consensus meetings; and 6) diverse representation on the steering committee and/or research team.

Limitations or Challenges

The CA of evidence-based interventions can be complex, challenging, demanding, and time- and resource-consuming, but it is essential to decrease and eliminate cancer health disparities and to achieve cancer health equity. CA interventions for cancer are few and emerging, which supports the critical need to increase its evidence base.

Table 2.

Using the ecological validity model in cultural adaptation of behavioral and psychosocial interventions in oncology

Ecological Validity Model Dimensions	Operational Definitions for our Cultural Adaptation Projects	Stakeholders: Target Audiencea	Stakeholders: Professionals Who Treat the Target Audienceb	Stakeholders: Professionals Who Deliver the Interventionc
Goals	Explicit goals of the intervention, including outcomes to be addressed	General acceptability Comprehensibility Applicability	Acceptability/appropriateness Comprehensibility Applicability	Acceptability/appropriateness Comprehensibility Applicability
Concepts	Specific theoretical concepts addressed in the intervention. Concepts addressed in different modules/sessions/sections, even if they are not addressed in the theoretical framework	General acceptability Comprehensibility Applicability	Acceptability/appropriateness Comprehensibility Applicability	Acceptability/appropriateness Comprehensibility Applicability
Strategies	Includes the intervention delivery mode, structure, length, frequency of contact, and intervention exercises/strategies (i.e., reading, reflections, worksheets, etc.)	Acceptability Feasibility	Acceptability Feasibility	Acceptability Feasibility
Content	Content of the intervention manual and patient manual	Comprehension and acceptability of the intervention’s patient facing materials	N/A	Comprehension and acceptability of the intervention manual contentd
Metaphors	Metaphors, stories, analogies, and metaphorical language used in the intervention	Comprehension and acceptability	N/A	Comprehension and acceptabilityd
Context	Points of entry, barriers, and facilitators for implementation, including recruitment, intervention delivery, retention. Questions of implementation (and analysis) can be guided by an implementation and dissemination research framework	Barriers and facilitators of patient’s participation	Multilevel Barriers and facilitators of implementation at the individual (patient), provider, interventionist, and setting (clinic or community site)	Multilevel Barriers and facilitators of implementation at the individual (patient), provider, interventionist, and setting (clinic or community site)

^aCancer patients, community members (for community-based interventions), caregivers, families, community health workers, and health care professionals or trainees

^bHealth professionals such as physicians, nurses, and advanced care professionals in oncology, palliative care, primary care, critical care, etc.

^cFor psychosocial interventions, mental health, supportive care, and community interventions, professionals can include psychologists, social workers, psychiatrists, community health workers, nurses, and other types of physicians.

^dOnly consulted about content and metaphors because the professionals that deliver the intervention are expected to have expertise in theoretical content, strategies, metaphorical language, etc.

KEY POINTS.

• Culturally adapting original evidence-based interventions is necessary to reach diverse cultural groups and to improve clinical and psychosocial outcomes.

• We present a step-by-step guide based on well-established models and frameworks for the cultural adaptation of interventions.

• We recommend using established research models and qualitative and quantitative data sources that incorporate multiple stakeholder perspectives.

• Our systematic approach aims to improve the validity and rigor of cultural adaptation of interventions in patients with cancer.