Hematologic MalignancyNCT05270655
Cognitive-behavioural Intervention for Anxiety, Depression and Quality of Life Among Children Receiving Chemotherapy.
A study testing Cognitive-behavioural intervention in people with Hematologic Malignancy and Anxiety, run by Chinese University of Hong Kong at 2 sites in Ethiopia.
Trial summary
The diagnosis and treatment of paediatric cancer is the most stressful experience for children and their families. Nearly all paediatric cancer patients are presented with at least one psychosocial problem, of which, anxiety and depression often coexist and are most frequently reported. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Hematologic Malignancy, Anxiety, Depression
- What is being tested?
- Cognitive-behavioural intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesEthiopia
- Study dates
- 12 Apr 2022to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8 to 18-year-old children
- Diagnosed with haematological cancer
- Receiving chemotherapy
- Able to communicate (speak, read and write) with the local language, Amharic
- Able to provide written parental consent and oral child assent
Who cannot join
- Have a history of developmental problems, psychological or psychiatric illness
- Unable to collaborate in the study due to acute illness
- Have hearing or speech problems
Trial locations and contacts
2 sites in 1 country.
Ethiopia2 sites
Tikur Anbesa specialised hospital
Addis Ababa
University of Gondar specialised hospital
Gonder
About this study
Official title: Effects of a Cognitive-behavioural Intervention on Anxiety, Depression and Quality of Life Among Ethiopian Children With Haematological Cancer Receiving Chemotherapy.
The diagnosis and treatment of paediatric cancer is the most stressful experience for children and their families. Nearly all paediatric cancer patients are presented with at least one psychosocial problem, of which, anxiety and depression often coexist and are most frequently reported. Poorly managed anxiety and depression causes emotional and behavioural problems, impairs relationships and functioning, decreases adhere to treatment, increases the burden of symptoms and significantly impacts quality of life and prognosis. Despite the high rates and negative impacts of anxiety and depression in paediatric oncology, they are poorly managed. Thus, to mitigate the burden of anxiety, depression and impaired quality of life, an age-appropriate cognitive-behavioural intervention shows promise when incorporated with the existing pharmacologic interventions.
This study aims to test how effective cognitive-behavioural intervention is to improve anxiety, depression and quality of life of children during chemotherapy.
Read more
The study will be conducted in two hospitals in Ethiopia and include 8-18-year-old children with haematological cancer receiving chemotherapy, able to communicate with the local language, Amharic, able to provide parental consent and child assent, and without history of developmental, psychological, psychiatric, hearing or speech problems.
The study will enroll up to 80 participants and randomise them into two groups, one group will receive a cognitive-behavioural intervention and the the other group will receive the usual psychosocial care provided by staff nurses. Participants in the cognitive-behavioural intervention group will receive five sessions of individual face to face cognitive-behavioural intervention. Each session will last approximately 30-35 minutes a week and supplemented by home-based practices. This study will use different intervention delivery strategies including psychoeducation, guided discovery or Socratic questioning, discussion, drawing, painting or writing, and play depending on the content of each session and maturity of the child.
The levels of anxiety, depression and quality of life will be measured before the intervention, after the intervention and one month after completion of the intervention in both groups.
Read the detailed description
The application of cognitive-behavioural therapy (CBT) has been used for the management of anxiety and depression. Nowadays, evidence suggests that CBT has promising effects on improving psychological and health-related outcomes in children with cancer. CBT is a structured, and tailored psychotherapeutic intervention based on cognitive and behavioural approaches that helps to understand the underlying thoughts, feelings, and behaviours that mitigate between the course of the illness and the outcomes. It helps to modify dysfunctional thoughts and beliefs, reduce maladaptive behaviour and increase adaptive skills. It enables the patients to control their emotions and behaviour, to become their own therapist, to make the interventions sustainable and prevent relapse.
A systematic review and meta-analysis conducted shows cognitive-behavioural therapy has been used to manage stressful experiences including anxiety and depression among children during the course of cancer treatment. However, the studies included heterogenous participants across the cancer trajectory and employed different intervention delivery strategies. Additionally, majority of the included studies didn't specify the theory guiding the intervention development. Thus, developing and evaluating theory driven and age appropriate cognitive-behavioural intervention strategies for children undergoing chemotherapy is worthy of research. In this study, the Beck's cognitive model will be adopted to develop theory driven and age appropriate effective cognitive-behavioural intervention strategies for children receiving chemotherapy. The model was selected based on the results of the systematic review and other literatures on CBT.
The model describes the interactions among cognition, affection, and behaviour. Accordingly, it is not only the stressor but the perceptions and beliefs of the individual, and interpretation of a particular stressor that affect the emotional, physiological, and behavioural responses. Children with cancer usually have negative perceptions and thoughts about the self and others, the illness, and treatments such as chemotherapy. These distorted thoughts and negative strategies are often associated with emotional disturbances such as anxiety and depression. Cognitive-behavioural intervention helps to identify and modify distorted thought and behaviour, and develop cognitive and behavioural adaptations to improve emotional and behavioural responses. Cognitive adaptation is mainly achieved through cognitive restructuring such as identifying and challenging distorted thoughts and misinterpretations and developing coping strategies. Behavioural adaptation is largely achieved through behavioural activation such as identifying and introducing joyful activities. Changes in cognitive processes and developing adaptive behavioural activities increases coping strategies and reduces anxiety and depression symptoms, increase psychosocial functioning and quality of life due to improvement in stressful symptoms.
This study aims to evaluate the effects of a theory-based cognitive behavioural-intervention on anxiety, depression and quality of life among Ethiopian children with haematological cancer receiving chemotherapy.
In this study, it is hypothesised that when compared to the control group, participants receiving a cognitive-behavioural intervention will have;
- Significantly decreased anxiety at the end of the intervention
- Significantly decreased depression at the end of the intervention
- Significantly increased quality of life at the end of the intervention
- Conditions
- Hematologic Malignancy, Anxiety, Depression, Quality of Life
- Being tested
- Cognitive-behavioural intervention
- Keywords
- Cognitive Behavioral Therapy, Anxiety, Depression, Quality of life, Children, Hematologic Malignancy, Chemotherapy, Ethiopia
- Medical subject headings
- Hematologic Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioural interventionOther
Participants in the experimental group will receive five sessions of cognitive-behavioural intervention. Each session will be conducted face-to-face for 30-35 minutes a week and supplemented by home-based practices. The first session is an introductory to cognitive-behavioural intervention, the second session includes identifying, evaluating and challenging maladaptive thoughts, beliefs and behaviour, the third session includes behavioural activation, the fourth session is deep breathing, and the last session includes treatment evaluation and relapse prevention. The interventions will be delivered before chemotherapy sessions to avoid fatigue and to increase the patient's engagement with the interventions. To establish a strong therapeutic alliance and enhance intervention delivery and family support, parents will be invited to attend the introduction of the first session and the summary of each session (the last five minutes).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioural intervention | Experimental | Five sessions of cognitive-behavioural intervention will be delivered on a weekly basis. Receives: Other: Cognitive-behavioural intervention |
| Usual care | No intervention | Participants in the control group will receive the usual psychosocial care provided by the staff nurses. To offer them attention, a research assistant in each hospital will meet them every week for 30 minutes to ask them about treatment adherence and any other concerns. The parents will be invited to attend it if they want to do so. Each participant will be given an appointment slip and reminded with a phone call two days before the next appointment. For participants whose medical appointment is more than a week, the research will contact them via phone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety level
Anxiety and depression will be assessed using a self-report 25-items (15-items for anxiety and 10-items for depression) Revised Child Anxiety and Depression Scale (RCADS). Each item will be rated on a four-point Likert scale (0-3) and the total score will be calculated by converting the row scores into T-scores. T scores of ≥65 to 70 and ≥ 70 show borderline clinical threshold and above clinical threshold respectively. The higher anxiety sub-scale score refers higher anxiety.
Measured: At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks)
Secondary outcomes (2)
Change in depression level
A self-report 25-items items Revised Child Anxiety and Depression Scale (RCADS) will be used to assess the level of depression. The higher depression sub-scale score refers to higher depression level.
Measured: At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks)
Change in quality of life
Quality of life will be assessed using a child-report Quality of Life Inventory Generic Core Score 4.0 (PedsQLTM 4.0 GCS) for ages (8-12 and 13-18). Each item will be scored on a five-point Likert scale (0-4). The total score will be calculated reversely scoring the 0-4 scale items and linearly transforming to 0-100. A higher score indicates higher quality of life.
Measured: At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start12 Apr 2022
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, multi-center, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tenaw Gualu MELESSE, Chinese University of Hong Kong
- Investigators
- Tenaw G Melesse, PhD (c), Principal investigator, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong KongJanita PC Chau, PhD, Study chair, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270655
- Sponsor's protocol ID
- CREC Ref. No.: 2021.729-T
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure privacy and confidentiality of the participants, individual participant data will not be shared.
Publications
Arslan FT, Basbakkal Z, Kantar M. Quality of life and chemotherapy-related symptoms of Turkish cancer children undergoing chemotherapy. Asian Pac J Cancer Prev. 2013;14(3):1761-8. doi: 10.7314/apjcp.2013.14.3.1761.
PubMed 23679270Flowers SR, Birnie KA. Procedural Preparation and Support as a Standard of Care in Pediatric Oncology. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5:S694-723. doi: 10.1002/pbc.25813.
PubMed 26700922Hsiao HJ, Chen SH, Jaing TH, Yang CP, Chang TY, Li MY, Chiu CH, Huang JL. Psychosocial interventions for reduction of distress in children with leukemia during bone marrow aspiration and lumbar puncture. Pediatr Neonatol. 2019 Jun;60(3):278-284. doi: 10.1016/j.pedneo.2018.07.004. Epub 2018 Jul 21.
PubMed 30100518Hyslop S, Davis H, Duong N, Loves R, Schechter T, Tomlinson D, Tomlinson GA, Dupuis LL, Sung L. Symptom documentation and intervention provision for symptom control in children receiving cancer treatments. Eur J Cancer. 2019 Mar;109:120-128. doi: 10.1016/j.ejca.2019.01.002. Epub 2019 Feb 1.
PubMed 30716715Lawlor C, Sharma B, Khondoker M, Peters E, Kuipers E, Johns L. Service user satisfaction with cognitive behavioural therapy for psychosis: Associations with therapy outcomes and perceptions of the therapist. Br J Clin Psychol. 2017 Mar;56(1):84-102. doi: 10.1111/bjc.12122. Epub 2016 Dec 2.
PubMed 27910997Levine DR, Mandrell BN, Sykes A, Pritchard M, Gibson D, Symons HJ, Wendler D, Baker JN. Patients' and Parents' Needs, Attitudes, and Perceptions About Early Palliative Care Integration in Pediatric Oncology. JAMA Oncol. 2017 Sep 1;3(9):1214-1220. doi: 10.1001/jamaoncol.2017.0368.
PubMed 28278329Li HC, Williams PD, Lopez V, Chung JO, Chiu SY. Relationships among therapy-related symptoms, depressive symptoms, and quality of life in Chinese children hospitalized with cancer: an exploratory study. Cancer Nurs. 2013 Sep-Oct;36(5):346-54. doi: 10.1097/NCC.0b013e31824062ec.
PubMed 23059766Li R, Ma J, Chan Y, Yang Q, Zhang C. Symptom Clusters and Influencing Factors in Children With Acute Leukemia During Chemotherapy. Cancer Nurs. 2020 Sep/Oct;43(5):411-418. doi: 10.1097/NCC.0000000000000716.
PubMed 31107701Lopez-Rodriguez MM, Fernandez-Millan A, Ruiz-Fernandez MD, Dobarrio-Sanz I, Fernandez-Medina IM. New Technologies to Improve Pain, Anxiety and Depression in Children and Adolescents with Cancer: A Systematic Review. Int J Environ Res Public Health. 2020 May 19;17(10):3563. doi: 10.3390/ijerph17103563.
PubMed 32438762Pitman A, Suleman S, Hyde N, Hodgkiss A. Depression and anxiety in patients with cancer. BMJ. 2018 Apr 25;361:k1415. doi: 10.1136/bmj.k1415. No abstract available.
PubMed 29695476Rossberg JI, Evensen J, Dammen T, Wilberg T, Klungsoyr O, Jones M, Boen E, Egeland R, Breivik R, Lovgren A, Ulberg R. Mechanisms of change and heterogeneous treatment effects in psychodynamic and cognitive behavioural therapy for patients with depressive disorder: a randomized controlled trial. BMC Psychol. 2021 Jan 22;9(1):11. doi: 10.1186/s40359-021-00517-6.
PubMed 33482927Walubita M, Sikateyo B, Zulu JM. Challenges for health care providers, parents and patients who face a child hood cancer diagnosis in Zambia. BMC Health Serv Res. 2018 May 2;18(1):314. doi: 10.1186/s12913-018-3127-5.
PubMed 29720168Yardeni M, Abebe Campino G, Hasson-Ohayon I, Basel D, Hertz-Palmor N, Bursztyn S, Weisman H, Pessach IM, Toren A, Gothelf D. Trajectories and risk factors for anxiety and depression in children and adolescents with cancer: A 1-year follow-up. Cancer Med. 2021 Aug;10(16):5653-5660. doi: 10.1002/cam4.4100. Epub 2021 Jul 26.
PubMed 34309238Zahed G, Koohi F. Emotional and Behavioral Disorders in Pediatric Cancer Patients. Iran J Child Neurol. 2020 Winter;14(1):113-121.
PubMed 32021635Zhang P, Mo L, Torres J, Huang X. Effects of cognitive behavioral therapy on psychological adjustment in Chinese pediatric cancer patients receiving chemotherapy: A randomized trial. Medicine (Baltimore). 2019 Jul;98(27):e16319. doi: 10.1097/MD.0000000000016319.
PubMed 31277176
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cognitive-behavioural Intervention on Anxiety, Depression and Quality of Life Among Ethiopian Children With Haematological Cancer Receiving Chemotherapy.
- ClinicalTrials.gov ID
- NCT05270655
- Acronym / sponsor ID
- CREC Ref. No.: 2021.729-T
- Conditions
- Hematologic Malignancy, Anxiety, Depression, Quality of Life
- Keywords
- Cognitive Behavioral Therapy, Anxiety, Depression, Quality of life, Children, Hematologic Malignancy, Chemotherapy, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The diagnosis and treatment of paediatric cancer is the most stressful experience for children and their families. Nearly all paediatric cancer patients are presented with at least one psychosocial problem, of which, anxiety and depression often coexist and are most frequently reported. Poorly managed anxiety and depression causes emotional and behavioural problems, impairs relationships and functioning, decreases adhere to treatment, increases the burden of symptoms and significantly impacts quality of life and prognosis. Despite the high rates and negative impacts of anxiety and depression in paediatric oncology, they are poorly managed. Thus, to mitigate the burden of anxiety, depression and impaired quality of life, an age-appropriate cognitive-behavioural intervention shows promise when incorporated with the existing pharmacologic interventions.
This study aims to test how effective cognitive-behavioural intervention is to improve anxiety, depression and quality of life of children during chemotherapy.
The study will be conducted in two hospitals in Ethiopia and include 8-18-year-old children with haematological cancer receiving chemotherapy, able to communicate with the local language, Amharic, able to provide parental consent and child assent, and without history of developmental, psychological, psychiatric, hearing or speech problems.
The study will enroll up to 80 participants and randomise them into two groups, one group will receive a cognitive-behavioural intervention and the the other group will receive the usual psychosocial care provided by staff nurses. Participants in the cognitive-behavioural intervention group will receive five sessions of individual face to face cognitive-behavioural intervention. Each session will last approximately 30-35 minutes a week and supplemented by home-based practices. This study will use different intervention delivery strategies including psychoeducation, guided discovery or Socratic questioning, discussion, drawing, painting or writing, and play depending on the content of each session and maturity of the child.
The levels of anxiety, depression and quality of life will be measured before the intervention, after the intervention and one month after completion of the intervention in both groups.
Detailed description
The application of cognitive-behavioural therapy (CBT) has been used for the management of anxiety and depression. Nowadays, evidence suggests that CBT has promising effects on improving psychological and health-related outcomes in children with cancer. CBT is a structured, and tailored psychotherapeutic intervention based on cognitive and behavioural approaches that helps to understand the underlying thoughts, feelings, and behaviours that mitigate between the course of the illness and the outcomes. It helps to modify dysfunctional thoughts and beliefs, reduce maladaptive behaviour and increase adaptive skills. It enables the patients to control their emotions and behaviour, to become their own therapist, to make the interventions sustainable and prevent relapse.
A systematic review and meta-analysis conducted shows cognitive-behavioural therapy has been used to manage stressful experiences including anxiety and depression among children during the course of cancer treatment. However, the studies included heterogenous participants across the cancer trajectory and employed different intervention delivery strategies. Additionally, majority of the included studies didn't specify the theory guiding the intervention development. Thus, developing and evaluating theory driven and age appropriate cognitive-behavioural intervention strategies for children undergoing chemotherapy is worthy of research. In this study, the Beck's cognitive model will be adopted to develop theory driven and age appropriate effective cognitive-behavioural intervention strategies for children receiving chemotherapy. The model was selected based on the results of the systematic review and other literatures on CBT.
The model describes the interactions among cognition, affection, and behaviour. Accordingly, it is not only the stressor but the perceptions and beliefs of the individual, and interpretation of a particular stressor that affect the emotional, physiological, and behavioural responses. Children with cancer usually have negative perceptions and thoughts about the self and others, the illness, and treatments such as chemotherapy. These distorted thoughts and negative strategies are often associated with emotional disturbances such as anxiety and depression. Cognitive-behavioural intervention helps to identify and modify distorted thought and behaviour, and develop cognitive and behavioural adaptations to improve emotional and behavioural responses. Cognitive adaptation is mainly achieved through cognitive restructuring such as identifying and challenging distorted thoughts and misinterpretations and developing coping strategies. Behavioural adaptation is largely achieved through behavioural activation such as identifying and introducing joyful activities. Changes in cognitive processes and developing adaptive behavioural activities increases coping strategies and reduces anxiety and depression symptoms, increase psychosocial functioning and quality of life due to improvement in stressful symptoms.
This study aims to evaluate the effects of a theory-based cognitive behavioural-intervention on anxiety, depression and quality of life among Ethiopian children with haematological cancer receiving chemotherapy.
In this study, it is hypothesised that when compared to the control group, participants receiving a cognitive-behavioural intervention will have;
- Significantly decreased anxiety at the end of the intervention
- Significantly decreased depression at the end of the intervention
- Significantly increased quality of life at the end of the intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, multi-center, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioural intervention | Experimental | Other: Cognitive-behavioural interventionFive sessions of cognitive-behavioural intervention will be delivered on a weekly basis. |
| Usual care | No intervention | –Participants in the control group will receive the usual psychosocial care provided by the staff nurses. To offer them attention, a research assistant in each hospital will meet them every week for 30 minutes to ask them about treatment adherence and any other concerns. The parents will be invited to attend it if they want to do so. Each participant will be given an appointment slip and reminded with a phone call two days before the next appointment. For participants whose medical appointment is more than a week, the research will contact them via phone. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 8 to 18-year-old children
- Diagnosed with haematological cancer
- Receiving chemotherapy
- Able to communicate (speak, read and write) with the local language, Amharic
- Able to provide written parental consent and oral child assent
Key exclusion criteria (3 listed)
- Have a history of developmental problems, psychological or psychiatric illness
- Unable to collaborate in the study due to acute illness
- Have hearing or speech problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioural interventionParticipants in the experimental group will receive five sessions of cognitive-behavioural intervention. Each session will be conducted face-to-face for 30-35 minutes a week and supplemented by home-based practices. The first session is an introductory to cognitive-behavioural intervention, the second session includes identifying, evaluating and challenging maladaptive thoughts, beliefs and behaviour, the third session includes behavioural activation, the fourth session is deep breathing, and the last session includes treatment evaluation and relapse prevention. The interventions will be delivered before chemotherapy sessions to avoid fatigue and to increase the patient's engagement with the interventions. To establish a strong therapeutic alliance and enhance intervention delivery and family support, parents will be invited to attend the introduction of the first session and the summary of each session (the last five minutes). | Other | Cognitive-behavioural intervention |
Primary outcome
Change in anxiety level
Time frame: At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks)
Anxiety and depression will be assessed using a self-report 25-items (15-items for anxiety and 10-items for depression) Revised Child Anxiety and Depression Scale (RCADS). Each item will be rated on a four-point Likert scale (0-3) and the total score will be calculated by converting the row scores into T-scores. T scores of ≥65 to 70 and ≥ 70 show borderline clinical threshold and above clinical threshold respectively. The higher anxiety sub-scale score refers higher anxiety.
2 secondary outcomes
Change in depression level
Time frame: At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks)
Change in quality of life
Time frame: At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 23679270Arslan FT, Basbakkal Z, Kantar M. Quality of life and chemotherapy-related symptoms of Turkish cancer children undergoing chemotherapy. Asian Pac J Cancer Prev. 2013;14(3):1761-8. doi: 10.7314/apjcp.2013.14.3.1761.
- Background: PubMed 26700922Flowers SR, Birnie KA. Procedural Preparation and Support as a Standard of Care in Pediatric Oncology. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5:S694-723. doi: 10.1002/pbc.25813.
- Background: PubMed 30100518Hsiao HJ, Chen SH, Jaing TH, Yang CP, Chang TY, Li MY, Chiu CH, Huang JL. Psychosocial interventions for reduction of distress in children with leukemia during bone marrow aspiration and lumbar puncture. Pediatr Neonatol. 2019 Jun;60(3):278-284. doi: 10.1016/j.pedneo.2018.07.004. Epub 2018 Jul 21.
- Background: PubMed 30716715Hyslop S, Davis H, Duong N, Loves R, Schechter T, Tomlinson D, Tomlinson GA, Dupuis LL, Sung L. Symptom documentation and intervention provision for symptom control in children receiving cancer treatments. Eur J Cancer. 2019 Mar;109:120-128. doi: 10.1016/j.ejca.2019.01.002. Epub 2019 Feb 1.
- Background: PubMed 27910997Lawlor C, Sharma B, Khondoker M, Peters E, Kuipers E, Johns L. Service user satisfaction with cognitive behavioural therapy for psychosis: Associations with therapy outcomes and perceptions of the therapist. Br J Clin Psychol. 2017 Mar;56(1):84-102. doi: 10.1111/bjc.12122. Epub 2016 Dec 2.
- Background: PubMed 28278329Levine DR, Mandrell BN, Sykes A, Pritchard M, Gibson D, Symons HJ, Wendler D, Baker JN. Patients' and Parents' Needs, Attitudes, and Perceptions About Early Palliative Care Integration in Pediatric Oncology. JAMA Oncol. 2017 Sep 1;3(9):1214-1220. doi: 10.1001/jamaoncol.2017.0368.
- Background: PubMed 23059766Li HC, Williams PD, Lopez V, Chung JO, Chiu SY. Relationships among therapy-related symptoms, depressive symptoms, and quality of life in Chinese children hospitalized with cancer: an exploratory study. Cancer Nurs. 2013 Sep-Oct;36(5):346-54. doi: 10.1097/NCC.0b013e31824062ec.
- Background: PubMed 31107701Li R, Ma J, Chan Y, Yang Q, Zhang C. Symptom Clusters and Influencing Factors in Children With Acute Leukemia During Chemotherapy. Cancer Nurs. 2020 Sep/Oct;43(5):411-418. doi: 10.1097/NCC.0000000000000716.
- Background: PubMed 32438762Lopez-Rodriguez MM, Fernandez-Millan A, Ruiz-Fernandez MD, Dobarrio-Sanz I, Fernandez-Medina IM. New Technologies to Improve Pain, Anxiety and Depression in Children and Adolescents with Cancer: A Systematic Review. Int J Environ Res Public Health. 2020 May 19;17(10):3563. doi: 10.3390/ijerph17103563.
- Background: PubMed 29695476Pitman A, Suleman S, Hyde N, Hodgkiss A. Depression and anxiety in patients with cancer. BMJ. 2018 Apr 25;361:k1415. doi: 10.1136/bmj.k1415. No abstract available.
- Background: PubMed 33482927Rossberg JI, Evensen J, Dammen T, Wilberg T, Klungsoyr O, Jones M, Boen E, Egeland R, Breivik R, Lovgren A, Ulberg R. Mechanisms of change and heterogeneous treatment effects in psychodynamic and cognitive behavioural therapy for patients with depressive disorder: a randomized controlled trial. BMC Psychol. 2021 Jan 22;9(1):11. doi: 10.1186/s40359-021-00517-6.
- Background: PubMed 29720168Walubita M, Sikateyo B, Zulu JM. Challenges for health care providers, parents and patients who face a child hood cancer diagnosis in Zambia. BMC Health Serv Res. 2018 May 2;18(1):314. doi: 10.1186/s12913-018-3127-5.
- Individual participant dataSharing planned: No. To ensure privacy and confidentiality of the participants, individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tenaw G Melesse, PhD (c) principal investigator
The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong
Janita PC Chau, PhD study chair
The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioural intervention in people with Hematologic Malignancy and Anxiety, run by Chinese University of Hong Kong at 2 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety level (time frame: At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270655, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.